NYO
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| EliA RNA Pol III (K202541) | Phadia AB | 2021-09-13 |
| ImmuLisa Enhanced RNA POL III Antibody ELISA (K172078) | Immco Diagnostics, Inc. | 2018-03-30 |
| QUANTA LITE RNA POL III ELISA (K070066) | Inova Diagnostics, Inc. | 2007-04-11 |
| ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 (K060431) | Mbl International Corporation | 2006-06-19 |
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Every clearance here is in the API, with alerts when new ones post.