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Tyrosine Phosphatase (Ia-2) Autoantibody Assay

FDA product code OIF · 3 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
2008-04-10 – 2023-08-24

The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).

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