NIY
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA definition
- ELISA for the detection of anti-SLA (soluble liver antigen) antibody of the IgG class. Intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) (K113439) | Euroimmun US | 2013-04-12 |
| EUROIMMUN ANTI-SLA/LP ELISA(LGG) (K112221) | Euroimmun US | 2012-09-11 |
| QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA (K021482) | Inova Diagnostics, Inc. | 2002-07-30 |
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Every clearance here is in the API, with alerts when new ones post.