Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
QEP is the FDA product code for Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections, a class II device type, regulated under 21 CFR 866.3393. FDA's definition for this code reads: "A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted...". As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 4 recalls.
Classification record
- Product code
- QEP
- Device name
- Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- FDA definition
- A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data.
- Regulation
- 21 CFR 866.3393
- 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
- 24
- Ingested recalls
- 4
Clearances, product code QEP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2019 | 5 |
| 2020 | 3 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 3 |
| 2025 | 4 |
| 2026 | 3 |
Applicants with the most clearances
Product code QEP| Applicant | Clearances |
|---|---|
| Roche Molecular Systems Inc | 7 |
| Hologic, Inc. | 5 |
| Visby Medical, Inc. | 3 |
| Abbott Molecular, Inc. | 2 |
| Binx Health, Inc. | 2 |
| BD Integrated Diagnostic Solutions/Becton | 1 |
| Becton Dickinson & Co | 1 |
| Cepheid | 1 |
| Neumodx Molecular, Inc. | 1 |
| Rheonix, 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.