PET — Anti-Ss-A Ro60 Autoantibodies Class II
FDA product code PET covers "Anti-Ss-A Ro60 Autoantibodies", a Class II medical device regulated under 21 CFR 866.5100. Submissions are reviewed by the Immunology panel.
Classification Details
- Product Code
- PET
- Device Class
- Class II
- Regulation Number
- 866.5100
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
Ro60 assays are designed for the determination of IgG anti-Ro60 (SS-A Ro60) autoantibodies in human serum. The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren's Syndrome.