Catalog Number

KAI-050

Brand Name

K-ASSAY® Fructosamine Reagent + Calibrator (L)

Version/Model Number

KAI-050

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 28, 2018

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)

Yes

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

cfdd0703-881e-4bf3-8469-8eb9d0c9a704

Public Version Date

January 01, 2019

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-