cholesterol reference method laboratory network … · chol slides gen 43; lot 3354-3709 ortho...

CHOLESTEROL REFERENCE METHOD

LABORATORY NETWORK (CRMLN)

LIST OF ANALYTICAL SYSTEMS & REAGENTS

CERTIFIED FOR TOTAL CHOLESTEROL (TC)

Date Updated: July 2020

The Cholesterol Reference Method Laboratory Network (CRMLN) has certified the following systems as having

documented traceability to the CDC Lipids Reference Laboratory for total cholesterol. Detailed description

about the analytical system evaluated, including instrument, calibrator, and reagent information, along with

contact information for each laboratory is listed in the following section. Certificates expire two years after the

certification date.

WENZHOU WEIRIKANG BIOLOGICAL TECHNOLOGY CO.,LTD

Guo Erhao

No. 118, sen Mao Road, Louqiao Industrial Park, Ouhai District, Wenzhou, Suwon-si

Gyeonggi-do, Republic of Korea

Phone: 18368766697

Instrument Reagent Reagent Lot(s) Calibrator Calibrator Lot(s) Matrix Certification Date Network Laboratory POC

Mindray Automatic

Biochemical Analyzer

WEIRIKANG Total Cholesterol

Detection Reagent Kit

201805045 WEIRIKANG TCHO Calibrators 201805045-1 Serum 8/13/2018 Beijing Institute of Geriatrics No

Abaxis, Inc.

Dennis M. Bleile

3240 Whipple Road

Union City, CA, USA

Phone: (510) 675-6515


Abaxis, Inc. Piccolo Xpress®

Chemistry Analyzer

Abaxis, Inc. Piccolo®Total

Cholesterol Test

8085BB2 Abaxis, Inc. Abaxis Internal Cal

Set

2494/I685/I699 Serum 8/24/2018 CEQAL Inc. Yes

Siemens Healthcare Diagnostics

Sheila Perez-Nunez

P.O. Box 6101, M/S 104

Newark, DE, USA

Phone: 1-302-631-9370



Dimension Vista® System


CHOL Flex®

18186AC Siemens Healthcare Diagnostics

Vista CHEM 1 Calibrator

8CM081 Serum 11/8/2018 CEQAL Inc. No


Dimension® RxL chemistry

clinical System


CHOL Flex®

GA9176 Siemens Healthcare Diagnostics

Cholesterol Calibrator

8ED009 Serum 11/8/2018 CEQAL Inc. No


Dimension® ExL™ chemistry

clinical System


CHOL Flex®





Dimension® ExL™ chemistry

clinical System


CHOL Flex®





Dimension Vista® System


CHOL Flex®

18186AC Siemens Healthcare Diagnostics

Vista CHEM 1 Calibrator

8CM081 Serum 11/8/2018 CEQAL Inc. No


Dimension® RxL chemistry

clinical System


CHOL Flex®




Alere Technologies AS

Lisa Bråten

Kjelsasveien 161

Oslo, Norway

Phone: +47 46441967


Alere Technologies AS Alere Afinion TM

AS100 analyzer


Lipid Panel

10198752 - - serum 12/20/2018 Erasmus MC Yes


AS100 analyzer


Lipid Panel



AS100 analyzer


Lipid Panel



AS100 analyzer


Lipid Panel



AS100 analyzer


Lipid Panel



AS100 analyzer


Lipid Panel



AS100 analyzer


Lipid Panel



AS100 analyzer


Lipid Panel



AS100 analyzer


Lipid Panel



AS100 analyzer


Lipid Panel



AS100 analyzer


Lipid Panel



AS100 analyzer


Lipid Panel


Alere Technologies AS Afinion 2 TM Alere Technologies AS Alere Afinion Lipid

Panel

10198440 - - Serum 12/27/2018 Erasmus MC No


Panel



Panel



Panel



Panel



Panel



Panel



Panel



Panel




Panel



Panel



Panel


Ortho Clinical Diagnostics

Michael Castro

100 Indigo Creek Drive, B313

Rochester, NY, USA

Phone: (585) 453-5585



VITROS 5,1 FS Chemistry

System


VITROS Chemistry Products

CHOL Slides

Gen 43; Lot 3354-3709 Ortho Clinical Diagnostics

VITROS Calibrator Kit 2

Kit 267 Serum 2/5/2019 NW Lipid Metabolism &

Diabetes Research Labs.

No


VITROS 350 Chemistry

System



CHOL Slides





No


VITROS XT 3400 Chemistry

System



CHOL Slides





No

Shenzhen Mindray Bio-medical Electronics Co., Ltd. Biochemistry Standardization Laboratory

Chunli,Zhang

Mindray building, Keji 12th Road South, Hi-tech Industrial Park,Nanshan, Shenzhen, 518057 P.R.China

, China

Phone: 0755-81885210/13339768662


Shenzhen Mindray Bio-

medical Electronics Co., Ltd.

BS-2000M Chemistry

Analyzer



Total Cholesterol Kit

141618012 Shenzhen Mindray Bio-


Multi Sera Calibrator

150118001 Venous Serum 2/14/2019 Beijing Institute of

Geriatrics

No



BS-830 Chemistry Analyzer








Geriatrics

No



BS-800M Chemistry

Analyzer








Geriatrics

No











Geriatrics

No











Geriatrics

No

ACON laboratories, Inc.

Bingchen Liu

10125 Mesa Rim Road

San Diego, CA, USA

Phone: 875-8021


ACON Laboratories, Inc

Mission Cholesterol

Monitoring System


Mission Cholesterol Test

Device

OCH8100005 ACON Laboratories, Inc 180601 whole blood 3/28/2019 Beijing Institute of

Geriatrics

Yes


Mission Cholesterol

Monitoring System



Device

OCH8100005 ACON Laboratories, Inc 180601 venous serum 3/28/2019 Beijing Institute of

Geriatrics

Yes


Mission Ultra Cholesterol

Monitoring System


CHOL Total Cholesterol

Test Strips

CH181101C-1 ACON Laboratories, Inc 180603 Fresh capillary (fingertip)

blood

3/28/2019 Beijing Institute of

Geriatrics

Yes


Mission Ultra Cholesterol

Monitoring System


CHOL Total Cholesterol

Test Strips

CH181101C-1 ACON Laboratories, Inc 180603 Whole blood 3/28/2019 Beijing Institute of

Geriatrics

Yes


Mission Cholesterol

Monitoring System



Device

OCH8100005 ACON Laboratories, Inc 180601 Fresh capillary (fingertip)

blood

3/28/2019 Beijing Institute of

Geriatrics

Yes


Mission Cholesterol

Monitoring System



Device

OCH8100005 ACON Laboratories, Inc 180601 Plasma 3/28/2019 Beijing Institute of

Geriatrics

Yes

Abbott Diagnostic Division

Dror Yahalom

1921 Hurd Drive.

Irving, TX, USA

Phone: 972-518-6716


Abbott Alinity Abbott Cholesterol 66459UN18 Abbott Multiconstituent Calibrator 29381FD01 Serum 4/2/2019 CEQAL Inc. No

Abbott Architect c16000 Abbott Cholesterol 15229UN18 Abbott Multiconstituent Calibrator 93207FD01 Serum 4/2/2019 CEQAL Inc. No



Roche Diagnostics GmbH

Dr. H Klima

-

Penzberg, Germany

Phone: -


Roche Diagnostics GmbH Cobas Roche Diagnostics GmbH

TCHOL2

37119001 Roche Diagnostics GmbH Cfas 186488 Serum 5/9/2019 Erasmus MC No

Roche Diagnostics GmbH Cobas Roche Diagnostics GmbH CHOL2 395167 Roche Diagnostics GmbH Cfas 186488 Serum 5/9/2019 Erasmus MC No

SHANGHAI KEHUA BIO-ENGINEERING CO., LTD.

Yu Chen

1189 NORTH QINZHOU ROAD, 200233, SHANGHAI, CHINA

, China

Phone: 021-64850088-5001


SHANGHAI KEHUA

LABORATORY SYSTEM CO.

LTD KHB ZY Automatic

Analyzer

SHANGHAI KEHUA BIO-

ENGINEERING CO., LTD.

KHB Total Cholesterol

Kit(Liquid)(CHOD-PAP

Method)

20180912 SHANGHAI KEHUA BIO-


KHB Clinical Chemistry

Calibrator level 2


Geriatrics

No

SHANGHAI KEHUA



Analyzer

SHANGHAI KEHUA BIO-




Method)




Calibrator level 2


Geriatrics

No

SHANGHAI KEHUA



Analyzer

SHANGHAI KEHUA BIO-




Method)




Calibrator level 2


Geriatrics

No

Polymer Technology Systems, Inc.

Michelle Deal

7736 Zionsville Road

Indianapolis, IN, USA

Phone: (317) 870-5610 Ext. 1102


Polymer Technology Systems

Cardio Chek® PA®

Polymer Technology Systems PTS

Panels ® Cardio Chek® PLUS®

P838 - - Whole Blood 6/14/2019 NW Lipid Metabolism & Diabetes

Research Labs.

Yes

Polymer Technology Systems

Cardio Chek® PLUS®

Polymer Technology PTS Panels ®

Cardio Chek® PLUS®

P838 - - Whole Blood 6/14/2019 NW Lipid Metabolism & Diabetes

Research Labs.

Yes

Siemens Healthcare Diagnostics Inc.

Sheila Perez-Nunez

P.O. Box 6101, M/S 104

Newark, DE, USA

Phone: 1-302-631-9370



Inc. ADVIA® 1800


CHOL_c

538CH Siemens Healthcare Diagnostics

Inc. ADVIA® Chemistry

Calibrator

298846A Serum 7/2/2019 CEQAL Inc. No


Inc. ADVIA® 1800


CHOL_2

543CH Siemens Healthcare Diagnostics

Inc. ADVIA® Chemistry

Calibrator

298846A Serum 7/2/2019 CEQAL Inc. No

Alere San Diego Inc.

Esther Pacheco

9975 Summers Ridge Rd, C-1031

San Diego, CA, USA

Phone: (858) 805-3942


Alere LDX Alere Lipid Profile 418759B Alere Multi-Analyte Controls C3447L1C Serum 7/29/2019 NW Lipid Metabolism & Diabetes Research Labs. Yes

Alere LDX Alere Lipid Profile 418758B Alere Multi-Analyte Controls C3447L1C Serum 7/29/2019 NW Lipid Metabolism & Diabetes Research Labs. Yes

Beckman Coulter

Sinead McCarthy

O'Callaghans Mills

Lismeehan, Ireland

Phone: 065 6831439


Beckman Coulter AU480 Beckman Coulter OSR6x16 2553 Beckman Coulter DR0070 6102K81 serum 9/26/2019 Erasmus MC No

Beckman Coulter AU680 Beckman Coulter OSR6x16 2553 Beckman Coulter 66300 119M serum 9/26/2019 Erasmus MC No

Beckman Coulter AU680 Beckman Coulter OSR6x16 2553 Beckman Coulter 66300 1121 serum 9/26/2019 Erasmus MC No


Beckman Coulter AU5800 Beckman Coulter OSR6x16 2553 Beckman Coulter 66300 119M serum 9/26/2019 Erasmus MC No

Beckman Coulter AU5800 Beckman Coulter OSR6x16 2553 Beckman Coulter 66300 1121 serum 9/26/2019 Erasmus MC No


Beckman Coulter DXC700AU Beckman Coulter OSR6x16 2553 Beckman Coulter 66300 119M serum 9/26/2019 Erasmus MC No

Beckman Coulter DXC700AU Beckman Coulter OSR6x16 2553 Beckman Coulter 66300 1121 serum 9/26/2019 Erasmus MC No

Beckman Coulter DXC700AU Beckman Coulter OSR6x16 2553 Beckman Coulter DR0070 6102K81 serum 9/26/2019 Erasmus MC No

HORIBA Medical

Benoit Ferran

Parc euromedecine

Rue duCaducee BP 7290, France

Phone: 33 (0) 4 99 65 30 05


HORIBA Medical ABX Pentra

400


Cholesterol CP

15906909 HORIBA Medical ABX Pentra

MultiCal

1806901 - 9/26/2019 Erasmus MC No


400


Cholesterol CP


MultiCal

1806901 - 9/26/2019 Erasmus MC No

HORIBA Medical ABX Pentra C

200


Cholesterol CP


MultiCal

1806901 - 9/26/2019 Erasmus MC No

HORIBA Medical ABX Pentra C

400


Cholesterol CP


MultiCal

1806901 - 9/26/2019 Erasmus MC No

B.M.L. Kawagoe Laboratory

Nobuki Arai

1361-1 Matoba,Kawagoe,Saitama,Japan 350-1101

Saitama, Japan

Phone: 049-232-0409


JEOL Ltd. Automatic

Analyzer

FUJIFILM Wako Pure

Chemical Corporation L-

type CHO ・M

R1: AH892 FUJIFILM Wako Pure

Chemical Corporation Multi

Calibrator Lipids

KP540 Venous Serum 10/3/2019 National Cerebral and

Cardiovascular Center,

Research Institute,

Department of Research

Promotion, Lipid Reference

Laboratory

No

DENKA SEIKEN Co.,Ltd.,KAGAMIDA FACTORY

Junichi Kuroi

1359-1,Kagamida,Kigoshi,Gosen,Niigata,Japan 959-1695

Niigata, Japan

Phone: 0250-42-7137


HITACHI Automatic

Analyzer

DENKA SEIKEN T-CHO(S)N

SEIKEN

R1:849081 DENKA SEIKEN Lipid-

Calibrator-D

889051 Venous Serum 10/3/2019 National Cerebral and


Research Institute,



Laboratory

No

JEOL Automatic Analyzer DENKA SEIKEN T-CHO(S)N

SEIKEN


Calibrator-D



Research Institute,



Laboratory

No

TOSHIBA Automatic

Analyzer

DENKA SEIKEN T-CHO(S)N

SEIKEN


Calibrator-D



Research Institute,



Laboratory

No

FUJIFILM Wako Pure Chemical Corporation, Diagnostics Research Laboratories

Shinji Matsugi

6-1,Takata-cho,Amagasaki,Hyogo,Japan 661-0963

Hyogo, Japan

Phone: 06-6499-9133


BECKMAN COULTER

Automatic Analyzer

FUJIFILM Wako Pure


Type CHO M

R1: XH044 FUJIFILM Wako Pure


Calibrator Lipids



Research Institute,



Laboratory

No

Hitachi Medical

Corporation Automatic

Analyzer

FUJIFILM Wako Pure


Type CHO M

R1: XH044 FUJIFILM Wako Pure


Calibrator Lipids



Research Institute,



Laboratory

No

Hitachi Chemical Diagnostics Systems Co., Ltd.Fuji Plant

Tomomi Murakami

600-1 Minami-ishiki Nagaizumi-cho, Sunto-gun, Shizuoka, Japan 411-0932

Shizuoka, Japan

Phone: 055-988-6014


Total Cholesterol Hitachi

High-Technologies

Hitachi 7180 Determiner L

TCⅡ

R1: 401AIG Hitachi Chemical

Diagnostics Systems

Co.,Ltd. Determiner

Standard Serum

401AIH Venous Serum 10/3/2019 National Cerebral and


Research Institute,



Laboratory

No

Total Cholesterol Hitachi

High-Technologies

Hitachi 7180 Determiner C-

TC

R1: 401AIG Hitachi Chemical

Diagnostics Systems

Co.,Ltd. Determiner

Standard Serum

401AIH Venous Serum 10/3/2019 National Cerebral and


Research Institute,



Laboratory

No

SEKISUI MEDICAL Co., Ltd., Tsukuba Plant

Yoshinori Motoyama

3-1, Koyodai 3-chome, Ryugasaki, Ibaraki, Japan 301-0852

Ibaraki, Japan

Phone: 0297-62-7551


Hitachi Medical


Analyzer

SEKISUI MEDICAL Co., Ltd.

Cholestest CHO

R1: 116RHQ SEKISUI MEDICAL Co., Ltd.

Cholestest N Calibrator

113REQ Venous Serum 10/3/2019 National Cerebral and


Research Institute,



Laboratory

No

Hitachi Medical


Analyzer


Pureauto S CHO-N

R1: 116RGQ SEKISUI MEDICAL Co., Ltd.




Research Institute,



Laboratory

No

Hitachi Medical


Analyzer


Cholestest CHO

R1: 116RHQ SEKISUI MEDICAL Co., Ltd.




Research Institute,



Laboratory

No

Hitachi Medical


Analyzer


Pureauto S CHO-N

R1: 116RGQ SEKISUI MEDICAL Co., Ltd.




Research Institute,



Laboratory

No

SRL,Inc

JUNKO NEMOTO

1006-1 Komiya-cho,Hachioji-shi,Tokyo,Japan 192-0031

Tokyo, Japan

Phone: 042-648-4360


JEOL Ltd. Automatic

Analyzer

SEKISUI MEDICAL Co.,Ltd.

Cholestest CHO

R1: 113RFQ SEKISUI MEDICAL Co.,Ltd




Research Institute,



Laboratory

No

Tosoh Corporation

Yusei ONO, Koji MAKI

Customer Support Center 2743-1, Hayakawa, Ayase-shi, Kanagawa 252-1123, Japan

Kanagawa, Japan

Phone: 467-76-5384


Tosoh Corporation

Automatic Analyzer

Tosoh Corporation [TOSOH]

Lipopropak

R1: LT-R103D Tosoh Corporation

Lipopropak® Calibrator Set

LT-S03D Venous Serum 10/3/2019 National Cerebral and


Research Institute,



Laboratory

No

UMA Co.,LtD.

Takeshi Yoshikai

2-19-6 Yokosuka Matsudo-city Chiba-Pref. Japan, 270-0031

Chiba, Japan

Phone: 047-710-4871


Hitachi Automatic Analyzer UMA Co.,LtD. MEASURE TC R1: 168AIH UMA Co.,LtD. Lipids

Calibrator

115B Venous Serum 10/3/2019 National Cerebral and


Research Institute,



Laboratory

No

Sekisui Diagnostics P.E.I Inc.

Cindy Tait

70 Watts Avenue

Charlottetown, PE, USA

Phone: 628-0927


Tokyo Boeki Medisys Inc.

SK500

Sekisui Diagnostics Sekisui

Diagnostics

55453 Exp. 2020-09-30 Sekisui Diagnostics DC-Cal 51054 Exp. 2020-05-31 serum 11/5/2019 CEQAL Inc. No

Beckman Coulter Inc

Steve Laub

2470 Faraday Ave, Carlsbad, Ca. 92010

Carlsbad, CA, USA

Phone: 438-6521


Beckman Coulter®, Inc.

Synchron Systems

Beckman Coulter®, Inc. M910008 Beckman Coulter®, Inc.

Synchron® Multicalibrator

M812002 Venous Serum 12/13/2019 CEQAL Inc. No

Beckman Coulter®, Inc. Beckman Coulter®, Inc. M910008 Beckman Coulter®, Inc.

Synchron® Multicalibrator

M812002 Venous Serum 12/13/2019 CEQAL Inc. No

TaiDoc Technology Crop.

Pei-Fen Yang

6F, No. 127, Wugong 2nd Rd., Wugu Dist., 24888

New Taipei City, Taiwan

Phone: 2-6625-8188#6214


TaiDoc Technology Corp. TaiDoc Technology Corp. WC19E116 - - Whole blood 1/8/2020 CEQAL Inc. Yes

TaiDoc Technology Corp. TaiDoc Technology Corp. WC19D110 - - Whole blood 1/8/2020 CEQAL Inc. Yes




TaiDoc Technology Corp. TaiDoc Technology Corp. WC19F105 - - Whole blood 1/8/2020 CEQAL Inc. Yes

TaiDoc Technology Corp. I1

Multi-Functional Monitoring

System

TaiDoc Technology Corp. I1

Total Cholesterol Test Strip

WC19F105 - - Whole blood 1/8/2020 CEQAL Inc. Yes

TaiDoc Technology Corp. TaiDoc Technology Corp. WC19E116 - - Whole blood 1/8/2020 CEQAL Inc. Yes

Roche Diagnostics Roche Cobas

C311 Analyzer

Roche Diagnostics CHOL2 434710 Roche Diagnostics CFAS 32403001 Serum 1/8/2020 CEQAL Inc. Yes

Home Access Health Corporation

Jason J. Yedlinski

2401 W Hassell Rd, Suite 1510

Hoffman Estates, IL, USA

Phone: (847) 310-6332


Beckman Coulter Inc.

Au680

Beckman Coulter Inc.

Cholesterol

2590 Beckman Coulter

Lyophilized Chemistry

Calibrator

6102K81 Dried Capillary Serum 2/20/2020 University of Washington,

Department of Medicine

Northwest Lipid

Metabolism and Diabetes

Research Laboratories

No

Medica Corporation

Sheldon S. Cantor

5 Oak Park Drive

Bedford, MA, USA

Phone: 781-541-7408


Medica Corporation EasyRA Medica CHOL Reagent Total

Cholesterol

19312 Medica Corporation EasyRA

Chemistry CAL

18122 Serum 3/17/2020 University of Washington,

Department of Medicine

Northwest Lipid Metabolism

and Diabetes Research

Laboratories

No

Abbott Diagnostic Division

Dror Yahalom

1921 Hurd Drive.

Irving, TX, USA

Phone: 972-518-6716


Abbott Architect c4000 Abbott Cholesterol 95932UI00 Abbott ConCC 961UE Serum 4/2/2019 CEQAL Inc. No



Abbott Alinity Abbott Cholesterol 95922UI00 Abbott ConCC 961UE Serum 4/2/2019 CEQAL Inc. No

Anhui Iprocom Biotech Co., Ltd. Biochemistry Standardization Laboratory

Haigang,Liang

Building 18, Liandong U Valley, Corner of Fanhua Street and Jilin Road,hefei,230000 P.R.China

P.R. China, China

Phone: 0551-65358887/18129830676


Beckman Coulter AU680

Chemistry Analyzer

Anhui Iprocom Biotech Co.,

Ltd. Total Cholesterol Kit

2020021001 Randox Laboratories

Limited ACUSERA CAL3

996UE Venous Serum 6/12/2020 Beijing Institute of

Geriatrics

No


Ltd. EPNK-600 Chemistry

Analyzer






Geriatrics

No

Hitachi Hitachi7180

Chemistry Analyzer






Geriatrics

No

Siemens Healthcare Diagnostics Inc.

Sheila Perez-Nunez

P.O Box 6101, ms 104

Newark, DE, USA

Phone: 302-631-9370



Inc. Atellica® CH 930 Analyzer


Inc. Atellica® CH Cholesterol_2

(Chol_2)

2909222 Siemens Healthcare Diagnostics

Inc. Atellica CH CHEM CAL

534179E Serum 6/24/2020 CEQAL Inc. No


Inc. Dimension® ExL™ with LM

Integrated Chemistry System


Inc. CHOL Flex® reagent

cartdridge ( DF27)

GE0225 Siemens Healthcare Diagnostics

Inc CHOL Calibrator ( DC16)

0CD003 Serum 6/24/2020 CEQAL Inc. No


Inc. Dimension® RxL® chemistry

clinical System


CHOL Flex® reagent cartridge

(DF27)

GE0225 Siemens Healthcare Diagnostics

Inc. CHOL Calibrator (DC16)

0CD003 Serum 6/24/2020 CEQAL Inc. No


Inc. Dimension Vista® System


Inc.

20058AD Vista Chem 1 Calibrator 0AM081 Serum 6/24/2020 CEQAL Inc. No

cholesterol reference method laboratory network … · chol slides gen 43; lot 3354-3709 ortho...

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