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System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

FDA product code QYA · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3385
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-01-30 – 2025-01-30

This device is an in vitro diagnostic system intended for self-collecting specimens in home settings or similar environments and testing in a clinical laboratory for detection of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections. The device is intended to aid in the diagnosis of sexually transmitted infections. The device is intended for prescription use or over-the-counter use.

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