Catalog Number

021561R

Brand Name

Glycated Hemoglobin (HbA1C) Analyzer IVD

Version/Model Number

G8-90SLR

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

-

Product Code

LCP

Product Code Name

Assay, Glycosylated Hemoglobin

Public Device Record Key

f936d9c2-06a1-4bda-8fa3-e61755ddeba9

Public Version Date

June 08, 2018

Public Version Number

2

DI Record Publish Date

April 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-