Catalog Number

8936049

Brand Name

VITROS

Version/Model Number

8936049

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

K953197

Product Code

DCK

Product Code Name

C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Public Device Record Key

f8aea2c3-2c20-49f3-b2e0-a6e60ffbd89d

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-