Catalog Number

-

Brand Name

QuikCoag PT-HS

Version/Model Number

2 mL

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K020840,K020840

Product Code

GJS

Product Code Name

Test, Time, Prothrombin

Public Device Record Key

f18ff10e-b36a-4f03-b10b-ade4a541701e

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

10627944000018

Quantity per Package

10

Contains DI Package

00627944000011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box