Catalog Number

CR-121-1

Brand Name

Slide Platelet Aggregation Test Reagent

Version/Model Number

CR-121-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K921118,K921118

Product Code

GFO

Product Code Name

Activated Partial Thromboplastin

Public Device Record Key

2798289e-a26b-4065-a2ce-17ec57a917b5

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 31, 2019

Package DI Number

10817869020011

Quantity per Package

6

Contains DI Package

00817869020014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

6 Pack