Catalog Number

03L8123

Brand Name

ARCHITECT

Version/Model Number

3L81-23

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

-

Product Code

CGX

Product Code Name

ALKALINE PICRATE, COLORIMETRY, CREATININE

Public Device Record Key

cdc7cfcc-4ee6-4d92-a87e-d6e3e34333c5

Public Version Date

June 22, 2020

Public Version Number

2

DI Record Publish Date

March 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-