Catalog Number

-

Brand Name

STA® - Staclot® Protein C 3

Version/Model Number

00737

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K861079

Product Code

GGP

Product Code Name

TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

Public Device Record Key

cab53647-ec06-4940-b688-afbfc190b75b

Public Version Date

May 03, 2021

Public Version Number

4

DI Record Publish Date

December 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-