QEP
- Product code
- QEP
- Device name
- Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3393
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 24 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260917 | 2026-07-08 | Roche Molecular Systems, Inc. | cobas CT/NG for use on the cobas 5800/6800/8800 syst… | |
| K253759 | 2026-05-15 | Roche Molecular Systems, Inc. | cobas liat CT/NG/MG nucleic acid test | |
| K253756 | 2026-05-15 | Roche Molecular Systems, Inc. | cobas liat CT/NG nucleic acid test | |
| K251501 | 2025-10-01 | Visby Medical, Inc. | Visby Medical Men's Sexual Health Test | |
| K243343 | 2025-04-22 | Bd Integrated Diagnostic Solutions/Bec… | BD CTGCTV2 | |
| K240217 | 2025-01-17 | Roche Molecular Systems, Inc. | cobas® liat CT/NG nucleic acid test | |
| K240197 | 2025-01-16 | Roche Molecular Systems, Inc. | cobas® liat CT/NG/MG nucleic acid test | |
| K230267 | 2023-12-22 | Neumodx Molecular, Inc. | NeuMoDx CT/NG Assay 2.0 | FDA |
Official FDA classification page: QEP
Classification and pathway per current FDA publications. Data from openFDA (CC0).