Catalog Number

20764957322

Brand Name

Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation

Version/Model Number

20764957322

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CKA

Product Code Name

NADH OXIDATION/NAD REDUCTION, ALT/SGPT

Public Device Record Key

450fdd0d-4b7f-4132-a2b5-4bb60cf8bd33

Public Version Date

January 26, 2021

Public Version Number

1

DI Record Publish Date

January 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-