Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
NYO is the FDA product code for Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody, a class II device type, regulated under 21 CFR 866.5100. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NYO
- Device name
- Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
- 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.
- Regulation
- 21 CFR 866.5100
- Device class
- Class II
- Review panel
- Immunology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code NYO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 1 |
| 2018 | 1 |
| 2021 | 1 |
Applicants with the most clearances
Product code NYO| Applicant | Clearances |
|---|---|
| Immco Diagnostics, Inc. | 1 |
| Inova Diagnostics, Inc. | 1 |
| Mbl International Corporation | 1 |
| Phadia AB | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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