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Insulin Autoantibody Kit

FDA product code OCN · 1 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
2007-07-13 – 2007-07-13

The device is used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.

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