NIY — Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis Class II
Classification Details
- Product Code
- NIY
- Device Class
- Class II
- Regulation Number
- 866.5660
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K113439 | euroimmun us | EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) | April 12, 2013 |
| K112221 | euroimmun us | EUROIMMUN ANTI-SLA/LP ELISA(LGG) | September 11, 2012 |
| K021482 | inova diagnostics | QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA | July 30, 2002 |