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Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

FDA product code PQA · 11 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3975
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-05-16 – 2026-07-16

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.

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