DeviceClearance

Product code NWG— Immunology

KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT

Classification name
Autoantibodies, Glutamic Acid Decarboxylase (Gad)
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Total cleared
2
First cleared
Most recent

FDA classification definition

“The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).”

— U.S. Food and Drug Administration, device classification record for product code NWG under 21 CFR 866.5660, via openFDA

Market context for product code NWG

FDA has cleared 2 devices under product code NWG between 2005 and 2007, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NWG

Recent clearances under product code NWG

Data sourced from openFDA. This site is unofficial and independent of the FDA.