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Anti-Ss-A 52 Autoantibodies

FDA product code OBE · 2 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5100
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2007-04-04 – 2026-05-08

The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.

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