Catalog Number

07876424190

Brand Name

Tina-quant CReactive Protein IV

Version/Model Number

07876424190

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

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

K192072

Product Code

DCN

Product Code Name

SYSTEM, TEST, C-REACTIVE PROTEIN

Public Device Record Key

c8915994-9b8f-42e8-a7b6-4bd94b158aaf

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-