Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
QOF is the FDA product code for Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, a class II device type, regulated under 21 CFR 866.3981. FDA's definition for this code reads: "A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial...". As of , FDA records hold 33 510(k) clearances under this code, the most recent dated , and 9 recalls.
Classification record
- Product code
- QOF
- Device name
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- FDA definition
- A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.
- Regulation
- 21 CFR 866.3981
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 36
- Ingested recalls
- 9
Clearances, product code QOF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2023 | 7 |
| 2024 | 9 |
| 2025 | 13 |
| 2026 | 6 |
Applicants with the most clearances
Product code QOF| Applicant | Clearances |
|---|---|
| BioFire Diagnostics, LLC | 6 |
| Cepheid | 4 |
| Roche Molecular Systems Inc | 4 |
| DiaSorin Molecular LLC | 3 |
| Hologic, Inc. | 3 |
| Qiagen | 3 |
| Abbott Molecular, Inc. | 1 |
| Autonomous Medical Devices Incorporated | 1 |
| Baebies Inc. | 1 |
| Baebies, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.