Catalog Number

-

Brand Name

Asserachrom® Total Protein S

Version/Model Number

00945

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

K954040

Product Code

GGP

Product Code Name

TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

Public Device Record Key

789aaab5-3edd-45c9-8b39-aa6bb5fe58d3

Public Version Date

May 03, 2021

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-