Catalog Number

7371282

Brand Name

ADVIA® Chemistry P5P Pyridoxal-5-Phosphate Reagents

Version/Model Number

10326245

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K991576,K991576

Product Code

CIT

Product Code Name

Nadh oxidation/nad reduction, ast/sgot

Public Device Record Key

6a558e51-ec2e-447b-875d-7f7cd37b6ade

Public Version Date

December 10, 2021

Public Version Number

6

DI Record Publish Date

February 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-