Catalog Number

AU-645B

Brand Name

Carolina Liquid Chemistries CRPhsWR

Version/Model Number

AU-645B

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

Yes

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

-

FDA Premarket Submission

-

Product Code

DCK

Product Code Name

C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Public Device Record Key

e409fe60-ac10-4424-8f46-d6ec49aeb937

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-