Catalog Number

03P56-50

Brand Name

Coag-Sense Test Strip Kit, 50 ct.

Version/Model Number

100218

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"

Yes

For Single-Use

Yes

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

-

Product Code

GJS

Product Code Name

Test, Time, Prothrombin

Public Device Record Key

11a189f9-f850-4f7f-ad53-8d5a6ab702a0

Public Version Date

September 17, 2021

Public Version Number

1

DI Record Publish Date

September 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-