Catalog Number

06K2642

Brand Name

ARCHITECT

Version/Model Number

6K26-42

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

K173833

Product Code

NQD

Product Code Name

CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Public Device Record Key

ba10c46f-f8f8-4d22-9940-8dcb20c8e8bb

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-