NWG · Class II · 21 CFR 866.5660

FDA Product Code NWG: Autoantibodies, Glutamic Acid Decarboxylase (gad)

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).

2
Total
2
Cleared
145d
Avg days
2005
Since

FDA 510(k) Cleared Autoantibodies, Glutamic Acid Decarboxylase (gad) Devices (Product Code NWG)

2 devices
1–2 of 2
No devices found for this product code.

About Product Code NWG - Regulatory Context