Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis
Device Code: 3063
Product Code(s):
NIY 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
Device Classification Information
| Device Type ID | 3063 |
| Device Name | Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis |
| Regulation Description | Multiple Autoantibodies Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5660 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NIY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3063 |
| Device | Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis |
| Product Code | NIY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Multiple Autoantibodies Immunological Test System. |
| CFR Regulation Number | 866.5660 [🔎] |
TPLC Last Update: 2019-04-02 20:23:17