SIH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.2920
- Medical specialty
- Microbiology
- FDA definition
- A device for home collection and transport of specimens by lay users for use in a cleared non-viral STI molecular assay is a device intended for use by lay users in home settings or similar environments for the collection and transportation of specimens for testing using a cleared non-viral STI molecular assay with which the device has been validated.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Colli-Pee•Dx Urine Collection Kit (K254121) | DNA Genotek, Inc. | 2026-06-10 |
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Every clearance here is in the API, with alerts when new ones post.