RFE MEMO

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Memo Rev. A CM-00289-B

Product Description(s): Inflammation Panel 3(Cyno) Kit

Catalog Number(s) / Size(s): K15191D-Series

Lot Number: K0040314

Based on additional testing, the original date of expiration for this kit has been extended by 12 months.

The expiration date of K0040314 has been extended to 31 Dec 2018.

The expiration dates for the following kit components have also been extended:

Description Lot Number Original

Expiration Date

New Expiration

Date

Inflammation Panel 3(Cyno) Plate Z0055563 31 JUL 2018 31 DEC 2018

Anti-human MCP-1 Antibody D0040551 31 Dec 2017 31 DEC 2018

Anti-human NGAL Antibody D0040552 31 Aug 2018 31 DEC 2018

Anti-human TIMP-1 Antibody D0040553 31 Dec 2017 31 DEC 2018

Inflammation Panel 3(Cyno) Calibrator Blend A0040159 31 Aug 2018 31 DEC 2018

Diluent 8 M0080028 31 Dec 2017 31 DEC 2018

Function Name Signature Date

Quality Assurance

This memo supersedes all other statements regarding date of expiration for this product.

Dawn Stollar 16 NOV 2017

CERTIFICATE OF ANALYSIS

COA-07396

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Product Description: Inflammation Panel 3(Cyno) Kit

Kit Catalog Numbers: K15191D-1, K15191D-2, K15191D-4

Kit Lot Number: K0040314

Expiration Date: 31 Dec 2017

Acceptance Data/ Percent Recovery Specifications:

Calibrator Control 1 Control 2 Control 3

Spot Name Recovery CV Recovery CV Recovery CV Recovery CV

1 MCP-1 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20%

2 NGAL 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20%

3 TIMP-1 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20% 80% - 120% < 20%

Acceptance Data/ Non Specific Binding Specifications:

Spot Name NSB Spec

1 MCP-1 < 1.0%

2 NGAL < 1.0%

3 TIMP-1 < 1.0%

Stock Concentration of Material Tested :

Spot Name Item Conc Units

1 MCP-1

20X Calibrator 17.54 ng/ml

Control 1 8.74 ng/ml

Control 2 0.797 ng/ml

Control 3 0.0688 ng/ml

2 NGAL

20X Calibrator 514 ng/ml

Control 1 233 ng/ml

Control 2 30.8 ng/ml

Control 3 3.78 ng/ml

3 TIMP-1

20X Calibrator 992 ng/ml

Control 1 468 ng/ml

Control 2 178 ng/ml

Control 3 23.8 ng/ml

CERTIFICATE OF ANALYSIS

COA-07396

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Concentrations provided in this table refer to the stock concentration of the calibrators. For top of the standard curve

concentrations, please refer to the Standard Curve Data

The calibrator and controls for this assay contain a human recombinant cytokine calibrator sequence that is highly homologous to

the non-human primate cytokine. This assay has been verified to cross-react with homologs of rhesus and cynomolgus monkeys.

See Product Insert for experimental data.

Standard Curve Data:

MCP-1 - Spot 1

Conc. ng/ml

ECL Signal

%CV

0.877 771,000 2.0

0.292 393,000 2.2

0.0974 148,000 2.4

0.0325 49,200 2.3

0.0108 14,200 2.5

0.00361 4,300 2.7

0.00120 1,400 4.4

0.00 205 10.0

NGAL - Spot 2

Conc. ng/ml

ECL Signal

%CV

25.7 240,000 3.1

8.57 109,000 3.0

2.86 40,700 3.5

0.952 14,300 2.6

0.317 4,880 3.2

0.106 1,860 3.3

0.0353 774 3.6

0.00 277 9.8

TIMP-1 - Spot 3

Conc. ng/ml

ECL Signal

%CV

49.6 419,000 3.4

16.5 152,000 3.9

5.51 24,900 4.7

1.84 3,400 4.4

0.612 778 4.1

0.204 325 4.2

0.0680 223 8.6

0.00 174 16.0

Components:

Description Lot Number Storage Temperature Expiration Date

Inflammation Panel 3(Cyno) Plate Z0055563 2-8°C 31 Jul 2018

Anti-human MCP-1 Antibody D0040551 2-8°C 31 Dec 2017

Anti-human NGAL Antibody D0040552 2-8°C 31 Aug 2018

Anti-human TIMP-1 Antibody D0040553 2-8°C 31 Dec 2017

Inflammation Panel 3(Cyno) Calibrator blend A0040159 ≤ -70°C 31 Aug 2018

Blocker A Not Kit Specific Room Temperature N/A

Diluent 8 M0080028 ≤ -10°C 31 Dec 2017

Diluent 11 M0110029 ≤ -10°C 31 Dec 2018

Read Buffer T(4X) Not Kit Specific Room Temperature N/A

Statement:

The above kit was tested using MSD procedures and it conforms to MSD's specifications. The above product is intended for

Research Use Only. Not for use in Diagnostic Procedures.

Name Function Signature Date

Review/Approval Quality Assurance

Dawn Stollar 10 OCT 2016