NYO — Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody Class II
Classification Details
- Product Code
- NYO
- Device Class
- Class II
- Regulation Number
- 866.5100
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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 other laboratory findings. For in-vitro diagnostic use.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K202541 | phadia | EliA RNA Pol III | September 13, 2021 |
| K172078 | immco diagnostics | ImmuLisa Enhanced RNA POL III Antibody ELISA | March 30, 2018 |
| K070066 | inova diagnostics | QUANTA LITE RNA POL III ELISA | April 11, 2007 |
| K060431 | mbl international corporation | ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 | June 19, 2006 |