Catalog Number

AU-212

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT AU-212

Version/Model Number

AU-212

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

KNK

Product Code Name

Acid, uric, uricase (colorimetric)

Public Device Record Key

2e4c5af0-e173-4704-8f5c-b5de9e3844db

Public Version Date

July 14, 2022

Public Version Number

1

DI Record Publish Date

July 06, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-