Catalog Number

10379673

Brand Name

ADVIA® Chemistry A1c_3 Hemoglobin A1c Reagents

Version/Model Number

10379673

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2021

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

-

Product Code

LCP

Product Code Name

ASSAY, GLYCOSYLATED HEMOGLOBIN

Public Device Record Key

4a9e4200-d6b5-4bc5-9190-d127f4a51b39

Public Version Date

November 18, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-