Catalog Number

-

Brand Name

Optilite C-Reactive Protein Reagent

Version/Model Number

NK044.OPT.A

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

K172868

Product Code

DCN

Product Code Name

System, Test, C-Reactive Protein

Public Device Record Key

bf581ccc-1e39-4aa6-91fb-01881ec1853f

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

May 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-