Catalog Number

-

Brand Name

ABX PENTRA LOW CRP CONTROL

Version/Model Number

1220001731

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K061138

Product Code

DCK

Product Code Name

C-Reactive Protein, Antigen, Antiserum, And Control

Public Device Record Key

84767794-e862-4ed9-844b-6dc634082cd3

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-