Catalog Number

5035C

Brand Name

DCA™ Systems Hemoglobin A1c Reagent Kit

Version/Model Number

10311134

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

K951361

Product Code

LCP

Product Code Name

ASSAY, GLYCOSYLATED HEMOGLOBIN

Public Device Record Key

7d1725da-5f65-44a3-b911-6630f316095a

Public Version Date

November 19, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-