KRONUS GLUTAMIC ACID DECARBOXYLASE RIA ANTIBODY KIT - An enzyme linked immunosorbent assay for the - KRONUS, INC.

Duns Number:181070814

Device Description: An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic a An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic acid decarboxylase (GAD) antibody in human serum.

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More Product Details

Catalog Number

KR6710

Brand Name

KRONUS GLUTAMIC ACID DECARBOXYLASE RIA ANTIBODY KIT

Version/Model Number

KR6710

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051061

Product Code Details

Product Code

NWG

Product Code Name

Autoantibodies, Glutamic Acid Decarboxylase (Gad)

Device Record Status

Public Device Record Key

67011a56-5c64-4e2b-910a-c43c9ced7cea

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KRONUS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24