Catalog Number

KAI-035

Brand Name

K-ASSAY® Fibrinogen Reagent + Calibrator

Version/Model Number

KAI-035

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 18, 2021

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K993482

Product Code

GIS

Product Code Name

Test, Fibrinogen

Public Device Record Key

81b0ada0-42e9-4c7b-a118-2f751171c112

Public Version Date

June 21, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-