Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
PQA · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3975
Classification
FDA Product Code
PQA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3975
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.