November 2007

Dear Laboratorian:

Enclosed is your new edition of the BBL™ Quality Control and Product Information (QC / PI) Manual for Plated and Tubed Media. Like the current manual, the newly revised manual contains the quality controland product information for our most popular plated and tubed media as well as all media exempt fromuser quality control testing as outlined in CLSI Approved Standard M22-A3: Quality Control for CommerciallyPrepared Microbiological Culture Media. The Foreword contains a complete list of all BBL exempt media(see page xii).

As you will see, the product descriptions have a new format. Specifically, rather than formatting the descriptions in a continuous fashion as was done with the current manual, each description is formattedindependently and includes all of the information previously contained in the General Technical Informationsections of the current manual. The new format will allow easier implementation of future updates to individual product descriptions. Please discard your old manual.

In addition to the new format, highlights of this edition include:

• Expanded list of media exempt from user QC testing as outlined in CLSI M22-A3

• The addition of PC Agar (an exempt medium) to the manual

• Changes in quality control procedures and test organisms made by our Quality Control Laboratory where appropriate

• Updated organism names to adopt recent changes in microbial taxonomy

• Revised text and references, where appropriate, to provide information on current microbiological procedures and identification tables

• A Table of Contents so that you can verify all product descriptions are present

Additional information on BBL brand media, other diagnostic products and CLSI standards is published inour newsletter, LabO™ – Microbiology News and Ideas. If you do not receive LabO, or if you have comments or questions regarding this Manual, contact BD Technical Services by phone (800) 638-8663 or e-mailTechnical_Services@bd.com.

Sincerely,

Mary J. Zimbro, MT(ASCP) Amy MahnsManager, Technical Information Product Manager, Prepared Media

BD Diagnostics7 Loveton CircleSparks, MD 21152-0999 USAtel: 800.638.8663www.bd.com/ds

Becton, Dickinson and Company

BBL™ Quality Control and Product Information Manual for Plated and Tubed Media

BD Diagnostics7 Loveton CircleSparks, MD 21152-0999 USATel: 800.638.8663www.bd.com/ds

BBLTM Quality Control and Product Information Manual for Plated and Tubed Media

Date: . . . . . . . . . . . . . . . . . . . . . . . . . . 2007/11Label Control Number:. . . . . . . . . . . . . . . . . L008111Catalog Number: . . . . . . . . . . . . . . . . . . . . . 222245

TABLE OF CONTENTS • iii

QUALITY CONTROL / PRODUCT INFORMATION

TABLE OF CONTENTS

Page

Foreword xi

Contents of Manual and Details of Usage xiii

Symbol Glossary xvi

Plated Media

Label ControlBBLTM Product Name Number Revision Level Revision Date

Bacteroides Bile Esculin Agar (BBE) L007348 Rev. 06 October 2006

BCYE Agar L007349 Rev. 07 February 2007

Bile Esculin Agar L007350 Rev. 10 April 2006

Brain Heart CC Agar with 10% Sheep Blood L008065 Rev. 06 August 2006and Gentamicin (Deep Fill)

Brain Heart Infusion Agar (Deep Fill) L007351 Rev. 05 May 2006

Brain Heart Infusion Agar with 10% Sheep Blood (Deep Fill) L007352 Rev. 06 January 2006

Brain Heart Infusion Agar with 10% Sheep Blood, L007353 Rev. 08 April 2006Gentamicin and Chloramphenicol (Deep Fill)

Brucella Agar with 5% Horse Blood L007354 Rev. 05 January 2006

Campy CVA Agar L007355 Rev. 05 January 2006

Campylobacter Agar with 5 Antimicrobics and 10% L007356 Rev. 11 September 2007 Sheep Blood (Blaser)

CDC Anaerobe 5% Sheep Blood Agar L007357 Rev. 09 April 2006

CDC Anaerobe 5% Sheep Blood Agar with Kanamycin L007358 Rev. 10 February 2007 and Vancomycin (KV)

CDC Anaerobe 5% Sheep Blood Agar with L007359 Rev. 08 December 2006Phenylethyl Alcohol (PEA)

CDC Anaerobe Laked Sheep Blood Agar with Kanamycin L007360 Rev. 10 February 2007 and Vancomycin (KV)

Chocolate II Agar L007361 Rev. 08 September 2007(GC II Agar with Hemoglobin and IsoVitaleXTM)

Chocolate II Agar with Bacitracin L007362 Rev. 04 October 2006

Chocolate II Agar with Pyridoxal L007362 Rev. 04 October 2006

Chocolate II Agar (GC II Agar with Hemoglobin L007364 Rev. 04 September 2007 and IsoVitaleXTM) and Martin-Lewis Agar - Bi-Plate

Chocolate II Agar (GC II Agar with Hemoglobin and L007365 Rev. 08 September 2007IsoVitaleXTM) & Modified Thayer-Martin (MTM II) Agar-Bi-Plate

CIN Agar L007366 Rev. 06 October 2006

CLED Agar L007367 Rev. 04 May 2006

• TABLE OF CONTENTSiv

Label ControlBBLTM Product Name Number Revision Level Revision Date

Columbia Agar with 5% Sheep Blood L007369 Rev. 06 August 2006

Columbia CNA Agar with 5% Sheep Blood L007370 Rev. 08 August 2006

Columbia CNA Agar with 5% Sheep Blood and L007371 Rev. 08 December 2006MacConkey II Agar- I PlateTM

Corn Meal Agar with Polysorbate 80 (Deep Fill) L007372 Rev. 06 August 2006

DNase Test Agar with Toluidine Blue L007373 Rev. 05 July 2006

EMB Agar, Modified, Holt-Harris and Teague L007374 Rev. 08 May 2006

Endo Agar L007375 Rev. 08 April 2006

EnterococcoselTM Agar L007376 Rev. 08 April 2006

GC-LectTM Agar L007377 Rev. 04 September 2007

GC-LectTM Agar, JEMBECTM L007377 Rev. 04 September 2007

Group A Selective Strep Agar with 5% Sheep Blood (ssATM) L007378 Rev. 07 May 2006

Group A Selective Strep Agar with 5% Sheep Blood (ssATM) L007379 Rev. 09 December 2006 & TrypticaseTM Soy Agar with 5% Sheep Blood (TSA II)-Bi-Plate

Haemophilus Test Medium Agar L007380 Rev. 06 February 2007

HBT Bilayer Medium L007381 Rev. 04 May 2006

Hektoen Enteric Agar L007382 Rev. 08 May 2006

Hemo ID QUAD (with Growth Factors) L007383 Rev. 05 December 2006

Inhibitory Mold Agar (Deep Fill) L007384 Rev. 06 May 2006

Inhibitory Mold Agar with Chloramphenicol and L007385 Rev. 07 September 2007Gentamicin (Deep Fill)

Inhibitory Mold Agar with Gentamicin (Deep Fill) L007385 Rev. 07 September 2007

Lecithin Lactose Agar L007386 Rev. 06 October 2006

Levine EMB Agar L007387 Rev. 09 October 2006

MacConkey II Agar L007388 Rev. 08 October 2006

MacConkey II Agar with Sorbitol 8807371 Rev. 01 October 2006

Mannitol Salt Agar L007389 Rev. 07 September 2007

Martin-Lewis Agar L007390 Rev. 08 September 2007

Martin-Lewis Agar, Gono-Pak L007390 Rev. 08 September 2007

Martin-Lewis Agar, JEMBECTM L007390 Rev. 08 September 2007

Middlebrook and Cohn 7H10 Agar (Deep Fill) L007391 Rev. 10 September 2007

Modified Thayer-Martin (MTM II) Agar L007392 Rev. 09 September 2007

Modified Thayer-Martin (MTM II) Agar, Gono-Pak L007392 Rev. 09 September 2007

Modified Thayer-Martin (MTM II) Agar, JEMBECTM L007392 Rev. 09 September 2007

Mueller Hinton II Agar L007393 Rev. 11 July 2006

Mueller Hinton Agar with 5% Sheep Blood L007394 Rev. 03 April 2006

Mueller Hinton Chocolate Agar L007396 Rev. 03 January 2006

MycoselTM Agar (Deep Fill) L007397 Rev. 06 January 2006

Neomycin Blood Agar L007398 Rev. 04 July 2006

Nutrient Agar (Deep Fill) L007399 Rev. 06 October 2006

Plated Media

TABLE OF CONTENTS • v

Label ControlBBLTM Product Name Number Revision Level Revision Date

Oxacillin Screen Agar (Mueller Hinton Agar with 6 µg/mL L007400 Rev. 07 July 2006Oxacillin and 4% NaCl)

PC Agar L009798 Rev. 00 July 2007

Phenylethyl Alcohol Agar with 5% Sheep Blood L007401 Rev. 07 May 2006

Sabouraud Brain Heart Infusion Agar (Deep Fill) L007402 Rev. 05 April 2006

Sabouraud Brain Heart Infusion Agar L007403 Rev. 08 April 2006 with Chloramphenicol and Cycloheximide (Deep Fill)

Sabouraud Dextrose Agar L007404 Rev. 09 May 2006

Sabouraud Dextrose Agar with Chloramphenicol (Deep Fill) L007405 Rev. 07 January 2006

Sabouraud Dextrose Agar, Emmons L007406 Rev. 09 August 2006

Salmonella Shigella Agar L007407 Rev. 08 July 2006

Schaedler Agar with Vitamin Kl and 5% Sheep Blood L007408 Rev. 07 October 2006

Schaedler K-V Agar with 5% Sheep Blood L007409 Rev. 06 October 2006

Selective 7H11 Agar (Deep Fill) L007410 Rev. 11 September 2007

Selective Streptococcus Agar 8808201 Rev. 01 August 2006

Serum Tellurite Agar L007411 Rev. 09 December 2006

Seven H11 Agar (Deep Fill) L007412 Rev. 11 September 2007

SXT Blood Agar L007413 Rev. 08 July 2006

TCBS Agar L007414 Rev. 07 October 2006

Thayer-Martin Selective Agar L007417 Rev. 07 September 2007

TrypticaseTM Soy Agar (Soybean-Casein Digest Agar) L007418 Rev. 08 September 2007

TrypticaseTM Soy Agar (150 mm) L007419 Rev. 07 May 2006

TrypticaseTM Soy Agar with 5% Horse Blood L007420 Rev. 04 July 2006

TrypticaseTM Soy Agar with 5% Sheep Blood (TSA II) L007421 Rev. 09 July 2006

TrypticaseTM Soy Agar with 10% Sheep Blood L007421 Rev. 09 July 2006

TrypticaseTM Soy Agar with 5% Sheep Blood (TSA II) and L007422 Rev. 08 September 2007Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleXTM) - I PlateTM

TrypticaseTM Soy Agar with 5% Sheep Blood (TSA II) L007423 Rev. 08 May 2006and Levine EMB Agar - I PlateTM

TrypticaseTM Soy Agar with 5% Sheep Blood (TSA II) L007424 Rev. 08 December 2006and MacConkey II Agar - I PlateTM

TrypticaseTM Soy Agar with 5% Sheep Blood (TSA II) L009211 Rev. 01 December 2006and MacConkey II Agar with MUG - I PlateTM

V Agar L007425 Rev. 06 May 2006

XLD Agar L007426 Rev. 09 September 2007

Plated Media

• TABLE OF CONTENTSvi

Tubed Media

Label ControlBBLTM Product Name Number Revision Level Revision Date

Acetamide Agar Slants L007431 Rev. 08 July 2006

Acetate Differential Agar Slants L007432 Rev. 06 May 2006

ATS Medium Slants L008067 Rev. 08 October 2006

Bile Esculin Agar Slants L007435 Rev. 08 December 2006

Blood Agar Slants L007436 Rev. 06 December 2006

Blood Culture Media L007437 Rev. 04 July 2006

Brain Heart CC Agar, MycoflaskTM L007439 Rev. 08 April 2006

Brain Heart Infusion L007440 Rev. 09 February 2007

Brain Heart Infusion with 6.5% Sodium Chloride L007440 Rev. 09 February 2007

Brain Heart Infusion with PABA and 0.1% Agar L007441 Rev. 06 August 2006

Brain Heart Infusion Agar L007442 Rev. 08 July 2006

Brilliant Green Bile Broth, 2% with Durham Tube L007443 Rev. 08 May 2006

Campylobacter Thioglycollate Medium with L007445 Rev. 09 December 2006 5 Antimicrobics

Chocolate II Agar Slants (GC II Agar with Hemoglobin L007446 Rev. 08 September 2007and IsoVitaleXTM)

Cooked Meat Medium L007448 Rev. 10 July 2006

CTA MediumTM L007450 Rev. 08 July 2006

CTA MediumTM with Dextrose L007450 Rev. 08 July 2006

CTA MediumTM with Lactose L007450 Rev. 08 July 2006

CTA MediumTM with Maltose L007450 Rev. 08 July 2006

CTA MediumTM with Mannitol L009478 Rev. 00 January 2006

CTA MediumTM with Salicin L009478 Rev. 00 January 2006

CTA MediumTM with Sorbitol L009478 Rev. 00 January 2006

CTA MediumTM with Sucrose L009478 Rev. 00 January 2006

CTA MediumTM with Xylose L009478 Rev. 00 January 2006

EnterococcoselTM Agar Slants L007452 Rev. 09 December 2006

EnterococcoselTM Broth L007453 Rev. 08 July 2006

Fluid Thioglycollate Medium L007454 Rev. 09 March 2007

GN Broth L007455 Rev. 10 February 2007

Indole Nitrite Medium L007456 Rev. 07 May 2006

Jordan’s Tartrate Agar Deeps L007457 Rev. 07 January 2007

Kligler Iron Agar Slants L007458 Rev. 07 February 2007

Lactose Broth with Durham Tube (Double Strength) L007459 Rev. 07 May 2006

Lauryl Sulfate Broth with Durham Tube L007460 Rev. 09 October 2006

Lauryl Sulfate Broth, Durham Tube (Double Strength) L007460 Rev. 09 October 2006

TABLE OF CONTENTS • vii

Label ControlBBLTM Product Name Number Revision Level Revision Date

Lim Broth L007461 Rev. 04 February 2007

Litmus Milk L007462 Rev. 09 May 2006

Loeffler Medium Slants L007463 Rev. 07 January 2007

Lowenstein-Jensen Medium L007464 Rev. 08 January 2007

Lowenstein-Jensen Medium with 5% Sodium Chloride L007464 Rev. 08 January 2007

Lysine Iron Agar Slants L007465 Rev. 07 January 2007

Malonate Broth, Ewing Modified L007466 Rev. 08 January 2007

Middlebrook 7H9 Broth with Glycerol L007467 Rev. 09 December 2006

Middlebrook and Cohn 7H10 Agar L007468 Rev. 09 September 2007

Moeller Decarboxylase Broth Base L009479 Rev. 00 January 2006

Moeller Decarboxylase Broth with Arginine L009479 Rev. 00 January 2006

Moeller Decarboxylase Broth with Lysine L007470 Rev. 08 February 2007

Moeller Decarboxylase Broth with Ornithine L007470 Rev. 08 February 2007

Moeller KCN Broth Base L007471 Rev. 06 May 2006

Motility Indole Ornithine (MIO) Medium L007472 Rev. 08 February 2007

Motility Test Medium L007473 Rev. 09 February 2007

MR-VP Broth L007474 Rev. 06 May 2006

Mueller Hinton II Broth (Cation-Adjusted) L007475 Rev. 11 July 2006

MycobactoselTM L-J Medium L007477 Rev. 08 October 2006

MycoselTM Agar L007479 Rev. 08 January 2007

Nitrate Broth with Durham Tube L007480 Rev. 07 May 2006

Nutrient Agar L007481 Rev. 08 July 2006

Nutrient Broth L007482 Rev. 08 October 2006

Nutrient Gelatin L007483 Rev. 06 January 2006

OF Basal Medium L007484 Rev. 08 March 2007

OF Medium with Dextrose L007484 Rev. 08 March 2007

OF Medium with Lactose L009476 Rev. 00 January 2006

OF Medium with Maltose L009476 Rev. 00 January 2006

OF Medium with Mannitol L009476 Rev. 00 January 2006

OF Medium with Sucrose L009476 Rev. 00 January 2006

OF Medium with Xylose L009476 Rev. 00 January 2006

Petragnani Medium Slants L007485 Rev. 08 July 2006

Phenol Red Broth Base L007486 Rev. 09 July 2006

Phenol Red Broth with Dextrose and Durham Tube L007486 Rev. 09 July 2006

Phenol Red Broth with Xylose and Durham Tube L007486 Rev. 09 July 2006

Phenol Red Broth with Adonitol and Durham Tube L009481 Rev. 00 January 2006

Tubed Media

Label ControlBBLTM Product Name Number Revision Level Revision Date

Phenol Red Broth with Arabinose and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Cellobiose and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Dulcitol and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Glycerol and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Inositol and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Inulin and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Lactose and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Maltose and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Mannitol and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Raffinose and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Rhamnose and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Salicin and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Sorbitol and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Sucrose and Durham Tube L009481 Rev. 00 January 2006

Phenol Red Broth with Trehalose and Durham Tube L009481 Rev. 00 January 2006

Phenylalanine Agar Slants L007487 Rev. 06 October 2006

Potato Dextrose Agar L007488 Rev. 08 May 2006

PseudoselTM Agar Slants L007489 Rev. 07 May 2006

Rapid Fermentation Medium, Base L007491 Rev. 08 July 2006

Rapid Fermentation Medium, Dextrose L007491 Rev. 08 July 2006

Rapid Fermentation Medium, Lactose L007491 Rev. 08 July 2006

Rapid Fermentation Medium, Maltose L007491 Rev. 08 July 2006

Rapid Fermentation Medium, Sucrose L007491 Rev. 08 July 2006

Sabouraud Dextrose Agar L007492 Rev. 08 March 2007

Sabouraud Dextrose Agar with Chloramphenicol L007492 Rev. 08 March 2007

Sabouraud Dextrose Agar, Emmons L007493 Rev. 07 August 2006

Sabouraud Liquid Broth, Modified (Antibiotic Medium 13) L007494 Rev. 07 May 2006

Salt Broth, Modified L007495 Rev. 08 May 2006

Schaedler Broth with Vitamin K1 L007496 Rev. 08 February 2007

Selenite-F Broth L007497 Rev. 09 February 2007

Serum Tellurite Agar Slants L007499 Rev. 08 October 2006

Seven H11 Agar Slants L007500 Rev. 09 September 2007

Seven H11 Agar Slants with Aspartic Acid and L007501 Rev. 07 October 2006Sodium Pyruvate

SF Broth L007502 Rev. 11 September 2007

SIM Medium L007503 Rev. 07 October 2006

Simmons Citrate Agar Slants L007504 Rev. 06 February 2007

• TABLE OF CONTENTSviii

Tubed Media

TABLE OF CONTENTS •

Label ControlBBLTM Product Name Number Revision Level Revision Date

ix

Sodium Hippurate Broth L007505 Rev. 05 May 2006

Standard Methods Agar (APHA) L007506 Rev. 08 October 2006

Standard Methods Agar with Lecithin and Polysorbate 80 L007507 Rev. 06 May 2006Deeps

Thioglycollate Medium, Enriched with Vitamin K1 L007509 Rev. 09 February 2007and Hemin

Thioglycollate Medium, Enriched L007510 Rev. 03 February 2007(with Vitamin K1 and Hemin), with Calcium Carbonate

Thioglycollate Medium, L007511 Rev. 06 May 2006Fluid without Dextrose or Eh Indicator

Thioglycollate Medium without Indicator-135C L007512 Rev. 10 February 2007

Todd Hewitt Broth L007513 Rev. 08 March 2007

Todd Hewitt Broth with Gentamicin and Nalidixic Acid L007514 Rev. 04 October 2006

TrypticaseTM Soy Agar L007516 Rev. 09 October 2006

TrypticaseTM Soy Broth L007517 Rev. 11 March 2007

TrypticaseTM Soy Broth with 6.5% Sodium Chloride L007517 Rev. 11 March 2007

TrypticaseTM Soy Broth with 5% Fildes Enrichment L009477 Rev. 00 January 2006

TSI Agar Slants L007520 Rev. 07 February 2007

Urea Agar Base Concentrate 10X L007521 Rev. 08 September 2007

Urea Agar Slants, Complete L007521 Rev. 08 September 2007

Urease Broth Concentrate 10X L007522 Rev. 07 July 2006

Urease Test Broth L007522 Rev. 07 July 2006

BBL, CTA Medium, Enterococcosel, GC-Lect, I Plate, IsoVitaleX, Mycobactosel, Mycoflask, Mycosel, Pseudosel, ssA and Trypticase are trademarks of Becton, Dickinson and Company. JEMBEC is a trademarkof Miles Scientific. ©2007 BD

Tubed Media

• TABLE OF CONTENTSx

FOREWORD • xi

In June 2004, the Clinical and Laboratory Standards Institute (formerly NCCLS) published a revision of the Approved Standard,Quality Control for Commercially Prepared Microbiological Culture Media. The revised standard, M22-A3, provides guidelinesfor quality control testing of microbiological culture media. The standard applies to commercial manufacturers, mediadistributors and actual users of the media. The standard covers bacteriological, mycological and mycobacteriological media,including biplates, “paddles” and other kits used for primary isolation. It excludes media used for the growth of parasites,viruses, mycoplasmas and chlamydiae. Mueller Hinton Agar is also excluded since this medium is included in another standard(CLSI document M6). Commercially prepared media which are packaged in kits consisting of two or more different substratesand used primarily for microbial identification are also excluded.

BD Diagnostics developed this Quality Control/Product Information Manual to document to our customers the completespecifications relative to the quality control procedures employed to evaluate each lot of BBLTM and/or MycoflaskTM brandprepared media, including the test organism battery and the criteria of acceptable performance for each specific medium.

With regard to lot-to-lot certification of acceptability, each sleeve of BBL brand prepared plated medium contains a label whichstates, “Lot Samples were tested and met product specifications and CLSI standards where relevant.” Each package or cartonof BBL brand tubed, bottled and Mycoflask brand media will also contain this label, or a label which states either “Samplesof this lot were tested and met CLSI standards and BBL specifications,” or “Samples of this lot were tested and met BBLspecifications,” depending upon whether the medium falls within the scope of the CLSI Approved Standard M22-A3. The usercan detach these labels and affix them to pertinent records. In addition, users can print a copy of our “Certificate of QualityAssurance for Prepared Media” by visiting our web site at www.bd.com/ds/technicalCenter/qcSheet.asp. This certificate servesas documentation that all of BD’s prepared media meet CLSI standards, as applicable.

The certification of acceptability satisfies a requirement published in regulations implementing the Clinical LaboratoryImprovement Amendments of 1988 (CLIA ‘88: Fed. Regist. 55:20943, May 21, 1990). CLIA ‘88 permits users of commerciallyprepared media to use manufacturer’s quality control checks if the laboratory has documentation to verify that themanufacturer has used the quality assurance practices approved by the U.S. Department of Health and Human Services inAppendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Subpart K, Part 1, Section493.1256), published by the Centers for Medicare and Medicaid Services (CMS).

The CMS document exempts users of commercially prepared microbiological culture media from performing quality controlchecks for sterility, growth, selectivity and/or inhibition and biochemical responses, if the laboratory is provided withdocumentation attesting that the manufacturer’s quality control practices conform to CLSI specifications. The complete list ofBBL media exempt from user quality control testing is listed on the following page.

As you review the information presented in this manual, pay particular attention to the extent of the Quality Controlprocedures. Each prepared medium formulation is challenged with a battery of organisms specifically selected to criticallyevaluate the performance of that specific medium.

BD Diagnostics concern for the quality of our media extends to the ingredients used to make them. Each lot of dehydratedbase medium is challenged with a broader battery of organisms than that used for the prepared plated, tubed and bottledmedia. We believe that BD Diagnostics Quality Control procedures are the most extensive of any manufacturer ofmicrobiological products in the world, assuring batch-to-batch uniformity and superior product performance when stored andused as directed. Even though each lot of medium you receive has passed these extensive Quality Control tests, we stronglyrecommend that you confirm the suitability of media at the time of use, and recommendations for minimal user qualitycontrol are included in the Quality Control descriptions. If you do elect to reduce your internal quality control testing for theprepared media specified in CLSI document M22-A3, you can be confident that the BBL brand product you are using meetsthe high quality levels you demand.

When Quality Counts—Count on BBLTM Media!

QUALITY CONTROL / PRODUCT INFORMATION

FOREWORD

• FOREWORDxii

BBL Exempt Media

The media classified as exempt in M22-A3 were selected from three surveys conducted by the College of American Pathologistsfollowing analyses of failure rates for the most commonly used commercially prepared media. The tables below list all of theexempt BBLTM and MycoflaskTM media that fall within the purview of M22-A3. These media are identified by the inclusion ofa section "CLSI Organisms" in the QUALITY CONTROL PROCEDURES section for each medium; or, in those cases where CLSI doesnot designate quality control organisms, a "NOTE" is included stating that the medium is exempt according to CLSI M22-A3.The exempt media listed in the tables do not need to be retested by users. All other media included in this manual must continueto be retested by users.

*Quality control testing of exempt media is strongly recommended by CLSI M22-A3 when using specialty media for recovery of fastidious organisms or anaerobes.

*Quality control testing of exempt media is strongly recommended by CLSI M22-A3 when using specialty media for recovery of fastidious organisms or anaerobes.

Bacteroides Bile Esculin Agar (BBE)BCYE Agar*Bile Esculin AgarBrain Heart Infusion Agar with 10% Sheep Blood,

Gentamicin and ChloramphenicolCDC Anaerobe 5% Sheep Blood AgarCDC Anaerobe 5% Sheep Blood Agar with Kanamycin

and Vancomycin*CDC Anaerobe Laked Sheep Blood Agar with Kanamycin

and Vancomycin*CIN AgarCLED AgarColumbia Agar with 5% Sheep BloodColumbia CNA Agar with 5% Sheep BloodEMB Agar, Modified, Holt-Harris and TeagueEnterococcoselTM AgarGC-LectTM Agar*Hektoen Enteric AgarInhibitory Mold AgarInhibitory Mold Agar with Gentamicin

Inhibitory Mold Agar with Chloramphenicol and GentamicinLevine EMB AgarMacConkey II AgarMannitol Salt AgarModified Thayer-Martin Agar*MycoselTM AgarPC Agar*Phenylethyl Alcohol Agar with 5% Sheep BloodSabouraud Dextrose AgarSabouraud Dextrose Agar, EmmonsSalmonella Shigella AgarSchaedler Agar with Vitamin K1 and 5% Sheep BloodSelective Streptococcus AgarSXT Blood AgarTCBS AgarThayer-Martin Selective Agar*TrypticaseTM Soy Agar with 5% Sheep BloodTrypticaseTM Soy Agar with 10% Sheep BloodXLD Agar

Exempt Plated Media

Bile Esculin Agar SlantsBlood Agar SlantsBlood Culture Media (SEPTI-CHEKTM)Brain Heart InfusionEnterococcoselTM Agar SlantsFluid Thioglycollate MediumGN BrothLim BrothLowenstein-Jensen Medium Slants, Bottles and MycoflaskTM

Middlebrook 7H9 Broth with GlycerolMycobactoselTM L-J Medium Slants and MycoflaskTM

MycoselTM Agar Slants, Bottles and MycoflaskTM

Potato Dextrose AgarSabouraud Dextrose Agar Slants, Bottles and MycoflaskTM

Sabouraud Dextrose Agar, Emmons, Slants, Bottles and MycoflaskTM

Selenite-F BrothSF BrothSimmons Citrate Agar SlantsThioglycollate Medium, Enriched with Vitamin K1 and HeminThioglycollate Medium without Indicator-135CTrypticaseTM Soy BrothTSI Agar SlantsUrea Agar Slants

Exempt Tubed Media

BBL, Enterococcosel, GC-Lect, Mycobactosel, Mycoflask, Mycosel, SEPTI-CHEK and Trypticase are trademarks of Becton, Dickinson and Company. ©2007 BD.

xiiiCONTENTS OF MANUAL AND DETAILS OF USAGE •

I INTRODUCTIONThis Quality Control/Product Information Manual provides BBLTM and/or MycoflaskTM brand prepared media users withcentralized up-to-date product information on BBL Prepared Media products. The product descriptions for plated and tubedmedia are in alphabetical order by product name as listed on the outside box label except for SEPTI-CHEKTM blood culturemedia which are listed under Blood Culture Media.

The information provided for each prepared medium is organized into two parts. The first section of each productdescription contains the QUALITY CONTROL PROCEDURES employed at BD Diagnostics for release testing of each lot ofmedium. The details of the performance test procedure are included so that the user can repeat testing, if desired.Recommended organism strains for User Quality Control are identified with an asterisk and are keyed to the CLSI standard,M22-A3, Quality Control for Commercially Prepared Microbiological Culture Media, for those specific media or types ofmedia specified in the standard. The quality control procedures described in this manual are employed for each mediumregardless of packaging configuration.

The second section of each product description, the PRODUCT INFORMATION section, contains pertinent informationconcerning product formulation and usage. This information is the equivalent of a package insert and enables the BBLQuality Control/Product Information (QC/PI) Manual to be a substitute for package inserts for the respective products. ATABLE OF CONTENTS is provided so that users can verify that all product descriptions are present.

Each product description has been assigned a Label Control Number which is located beneath the title (e.g., LXXXXXX-Rev. 09). The “Rev. 09” portion of the number indicates the revision level (i.e., Rev. 09 means the insert is in the ninthrevision). Questions regarding the current revision levels should be directed to Technical Services, toll free (800) 638-8663.

Furthermore, the manual is divided into two sections – one for plated media and another for tubed media – details of whichare provided below. In addition, for your convenience a copy of our International Symbol Glossary is included at the endof this section. This glossary contains the symbols and definitions that are used on labels for all BD Diagnostics mediaproducts.

II PLATED MEDIASince 1960, BD Diagnostics has been the leading manufacturer of prepared plated media. BBLTM brand prepared platedmedia consist of BBL culture media in disposable Petri dishes ready for immediate use. Plated media are primarily suppliedin easy-open packages of twenty and cartons of one hundred 100 x 15 mm-style space-saving StackerTM dishes, designed tointerlock to minimize the hazard of sliding stacks. Some media are supplied in alternative packaging configurations.

Some media are also supplied in 150 x 15 mm-style dishes, including those for use in antimicrobial susceptibility testingby the agar diffusion disc method.

Prepared StackerTM I PlateTM and Bi-Plate dishes contain the same medium on each side of the dish divider, or two differentmedia for selective isolation or differentiation of microorganisms.

Quad plates are four-sectored dishes containing the same medium in each sector or different media in each sector tofacilitate organism differentiation.

JEMBECTM and Gono-Pak systems offer the advantage of a self-contained CO2-supplemented atmosphere. The JEMBEC plateconsists of a rectangular-shaped plate with a reservoir to hold a CO2-generation tablet and a snap-on lid. The Gono-Pakconsists of a 100 x 15 mm-style plate. Both systems are packaged with bags and CO2 tablets.

Each lot of BBL prepared plated media is manufactured from pretested components and the final product is quarantinedduring quality control testing.1

Routine shipments are made via refrigerated trucks to conveniently located Distribution Centers, where products aremaintained under controlled conditions for prompt local delivery.

BBL prepared plated media are for the isolation of microorganisms from samples or specimens by streak plate procedures.Generally, one specimen is streaked on a plate. Two specimens may be streaked on the two-sectored dishes containing asingle medium, or one specimen may be streaked on each side of a plate containing two different media; i.e., a selective anda nonselective medium.

QUALITY CONTROL / PRODUCT INFORMATION

CONTENTS OF MANUAL AND DETAILS OF USAGE

xiv • CONTENTS OF MANUAL AND DETAILS OF USAGE

III TUBED MEDIASince 1950, BD Diagnostics has been the leading manufacturer of prepared tubed media. BBLTM brand prepared tubed mediaconsist of BBL brand culture media in screw-capped tubes of a variety of sizes ready for immediate use. Some formulationsare also supplied in a variety of bottles and MycoflaskTM brand bottles, which provide a greater surface area for inoculation.

Each lot of BBL brand prepared tubed, bottled and Mycoflask brand media is manufactured from pretested componentsand the final product is quarantined during quality control testing.1

A. Prepared Tubed MediaCompletely prepared, ready-to-use culture media provide the correct tool for those bacteriologists whose workloadis such that the purchase of high-quality finished media is economically sound. Tested both in process and afterpreparation, they provide the microbiologist with reliable, ready-to-use media that ensure productivity.

BBL brand prepared tubed media reduce possible contamination. Larger-sized tubes permit easy inoculation orstreaking of media. Special long-necked, rubber gasket-lined screw caps reduce the chance of contamination ofcultures.

Prepared tubed media are supplied in tubes with optimal dimensions that provide a large surface for inoculation ofslant cultures. This is, of course, especially desirable in examining specimens for mycobacteria and fungi.

In some tubes, the agar may become distorted during shipment. These can be restored to their proper condition, withthe exception of heat-labile media (e.g., blood agar slants, egg-based media, etc.), by bringing to 100°C in a boilingwater bath* and resolidifying in the appropriate position.

Tubes of coagulated egg media may appear to have a large amount of water at the bottom of the slants due to storagein the upright position. The fluid will be reabsorbed into the medium if the tubes are placed on their sides so that the fluidcovers the surface of the slant. Storage in this position will result in virtually complete reabsorption of excess fluid.

Media (including all thioglycollate-containing media) may become oxidized within the tube during storage. Boilingin a water bath* serves to reduce media intended for the cultivation of anaerobic organisms; screw caps should beslightly loosened prior to boiling and retightened while cooling to room temperature. After boiling, thioglycollatemedia should be clear, but the agar haze may reappear upon cooling.

Some media (e.g., semisolid formulations) require heating with loosened caps in a boiling water bath* and coolingto room temperature prior to use to reestablish the correct consistency for accurate motility evaluations or to removedissolved oxygen. Tubed media in deeps must be melted in a boiling water bath*, cooled to 45 to 50°C, poured intosterile Petri dishes and allowed to harden for a minimum of 30 min prior to use.

Air bubbles should be removed from Durham tubes prior to incubation by inverting the broth tube and gentlytapping the side to dislodge the air bubble. Return the broth tube to the upright position, taking care to avoidreintroducing air into the Durham tube.

Cultures requiring prolonged incubation in a CO2-enriched (e.g., mycobacterial) or aerobic (e.g., fungal) atmosphereshould have loose caps during the first 3 weeks to allow exchange of gases; thereafter, they should be incubated withcaps tightly closed to prevent dehydration and consequent inhibition of growth, with weekly loosening and tighteningof caps to allow for gas exchange.

BBL brand prepared tubed media are provided in several sizes of glassware dependent upon the application of theindividual culture medium. Catalog listings indicate the type of tube in each instance; dimensions of each of the tubesare shown below.

A tube size 19.5 x 148 mm with cap E tube size 13 x 102 mm with cap

C tube size 19.5 x 115 mm with cap K tube size 16.5 x 105 mm with cap

D tube size 16.5 x 128 mm with cap

Most media are available in packages of 10 and cartons of 100 tubes to meet the volume needs of various users.

The “A” tubes consisting of solid media (e.g., TrypticaseTM Soy Agar), except slants, contain a quantity sufficient to pourone plate (approximately 20 mL). These are designated as “deeps” (pour tubes).

“A” tube slants for cultivation on the agar surface contain approximately 9 mL of media slanted at an angle to yielda slope of approximately 10 cm in length.

“A” tubes containing liquid culture media such as Fluid Thioglycollate Medium, unless otherwise noted, are filled tocontain approximately 20 mL.

The “C” tube is used primarily for fungal and mycobacterial culture media.

The “D” tube is utilized for certain general-purpose and special-purpose media. These are filled usually withapproximately 10 mL of medium.

The “E” tube is used for certain media where a low fill-volume is desired; i.e., 5 mL or less.

The “K” tube provides the convenience of a wide mouth with vertical shelf space saving. Unless otherwise noted, slantscontain approximately 4 mL, slants with butts approximately 6 mL and broths approximately 5 to 8 mL.

* Use of a microwave oven is not recommended.

xv

B. Mycoflask Bottled MediaMycoflask brand media are disposable ready-to-use BBL brand culture media prepared in the special Mycoflask brandbottle. A limited variety of media for isolation and cultivation of tubercle bacilli and fungi is offered. The Mycoflaskbrand bottle’s special features include:

Mycoflask brand media are packaged in specially designed trays for ease in handling and incubation; these UnitBoxes contain 10 bottles. The Shelf-Pack contains 10 Unit Boxes (10 x 10 bottles).

IV QUALITY CONTROL

A. OrganismsIn the individual “QUALITY CONTROL PROCEDURES” sections, the control ATCCTM strains specified in the CLSI standardM22-A3, Quality Control for Commercially Prepared Microbiological Culture Media,2 are listed when the standardapplies to the medium under discussion. Additional strains utilized by BD Diagnostics may also be listed. If no standardexists for the particular medium, the organisms listed represent only our test battery.

Cultures in BD Diagnostics Standard Test Methods are added or changed from time to time as strains are found whichprovide a greater challenge. Clinical isolates are included periodically for various formulations so as to checkperformance with “wild” strains.

NOTE: Except in those circumstances where CLSI or the United States Pharmacopeia (USP) require a specific ATCC strainbe used for a given product, the user may validate an ATCC strain other than the one listed. However, the validationprotocol is the user’s responsibility; BD is not responsible for the performance of these strains with our products.

B. Testing

Media that are exempt from user QC testing according to CLSI M22-A3 do not need to be retested by users. All othermedia included in this manual must continue to be retested by users. For users who are QC testing media (exempt ornonexempt), the recommended test strains are listed in the section on “QUALITY CONTROL PROCEDURES” and areidentified with an asterisk. The organisms identified with an asterisk are sufficient to determine acceptability of theparticular medium, including such characteristics as growth, selectivity and/or inhibition and biochemical responses.

The section on “ADDITIONAL QUALITY CONTROL” is provided so that users are aware of the entire scope of testingperformed by BD including pH (if applicable) and sterility testing.

V CE MARKED INSERTS

Inserts containing a CE Mark in the header or under AVAILABILITY have met the requirements of the European In VitroDiagnostic Device Directive (IVDD 98/79/EC). Contact your local BD representative for translated instructions.

VI FUTURE UPDATES

BD Diagnostics will continue to expand the products which are included in this manual. These additions, with any updates toexisting Quality Control/Product Information sheets, will be mailed to you as they become available. If you wish to updateyour mailing address or telephone number, please visit our web site at www.bd.com/ds/update. In order to ensure thatthis information is not overlooked when received at your laboratory, the envelope will be marked, “Important-QualityControl/Product Information Updates.” A responsible individual should be assigned to keep the manual updated. In addition,the entire manual is available on our website www.bd.com/ds. Revisions to product descriptions will be posted here as well.

We are certain you will be pleased with the content of this manual. We look forward to providing your facility with thehighest quality prepared media products available in today’s marketplace.

VII REFERENCES1. Power, D.A. 1975. Quality control of commercially prepared bacteriological media, p. 47-53. In J.E. Prier, J.T. Bartola, and H. Friedman (ed.), Quality control in microbiology. University

Park Press, Baltimore.2. Clinical and Laboratory Standards Institute. 2004. Approved Standard M22-A3. Quality control for commercially prepared microbiological culture media, 3rd ed. CLSI, Wayne, Pa.

CONTENTS OF MANUAL AND DETAILS OF USAGE •

• A deep offset well to contain a deep culture bed.

• Surface area of 5.4 cm2 for cultivation.

• Horizontal incubation to flood agar surface with inoculum.

• Flat-sided bottle to reduce chances of breakage.

• Tightly fitted screw caps to eliminate loss of moistureeven when incubation is extended.

ATCC is a trademark of the American Type Culture Collection. JEMBEC is a trademark of Miles Scientific. BBL, I Plate, Mycoflask, SEPTI-CHEK and Stacker are trademarks of Becton, Dickinsonand Company. ©2007 BD.

xvi • SYMBOL GLOSSARY

SYMBOL GLOSSARY

. . . . Manufacturer

e . . . . Use by: YYYY-MM-DD / YYYY-MM (MM = end of month)

r . . . . Catalog number

. . . . Authorized Representative in the European Community

I . . . . In Vitro Diagnostic Medical Device

L . . . . Batch Code (lot)

0 . . . . Temperature limitation

. . . . Consult instructions for Use

l . . . . Keep away from light

Unless otherwise noted, BD, BD Logo and all other trademarks are property of Becton, Dickinson and Company. ©2007 BD.

BD Diagnostics7 Loveton CircleSparks, MD 21152-0999 USATel: 800.638.8663www.bd.com/ds