Definition: The Anti-rna Polymerase Iii Test Is A Semi-quantitative Elisa For The Detection Of Anti-rna Polymerase Iii Antibodies In Human Serum. The Test Result Is Used As An Aid In The Diagnosis Of Systemic Sclerosis (ssc) In Conjunction With The Clinical And
| Device Type ID | 3077 |
| Device Name | Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody |
| Physical State | Antibody ELISA Kit, Antigen And Controls |
| Technical Method | The ELISA Test Result Aids In The Diagnosis Of Systemic Sclerosis (SSc) |
| Target Area | Blood Serum |
| Regulation Description | Antinuclear Antibody 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 | 866.5100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NYO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3077 |
| Device | Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody |
| Product Code | NYO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antinuclear Antibody Immunological Test System. |
| CFR Regulation Number | 866.5100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IMMCO DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |