Catalog Number

CC646

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.® CRP-W WIDE RANGE CC646

Version/Model Number

CC646

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 27, 2018

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

7d2d5b69-33f6-49d1-af87-2a55e4c8a83d

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-