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FDA PRODUCT CODE · CLASS II

QEP — Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.3393
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES

Recent clearances

K260917Roche Molecular Systems, Inc. · 510k2026-07-08
K253756Roche Molecular Systems, Inc. · 510k2026-05-15
K253759Roche Molecular Systems, Inc. · 510k2026-05-15
K251501Visby Medical, Inc. · 510k2025-10-01
K243343Bd Integrated Diagnostic Solutions/Becton, · 510k2025-04-22
K240217Roche Molecular Systems, Inc. · 510k2025-01-17
K240197Roche Molecular Systems, Inc. · 510k2025-01-16

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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