QYA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3385
- Medical specialty
- Microbiology
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| simpli-COLLECT STI Test (K243410) | Abbott Molecular | 2025-01-30 |
| Simple 2 Test (DEN200070) | Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) | 2023-11-15 |
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Every clearance here is in the API, with alerts when new ones post.