OBE
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Anti-Ss-A 52 Autoantibodies
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA definition
- 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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| Record | Firm | Date |
|---|---|---|
| Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB (K250814) | Zeus Scientific | 2026-05-08 |
| QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS (K141655) | Inova Diagnostics, Inc. | 2015-03-05 |
| QUANTA LITE SS-A 52 ELISA (K063565) | Inova Diagnostics, Inc. | 2007-04-04 |
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Every clearance here is in the API, with alerts when new ones post.