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Autoantibodies, Glutamic Acid Decarboxylase (Gad)

FDA product code NWG · 2 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5660
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2005-11-04 – 2007-11-07

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).

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