FDA product code SIH: Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay
SIH is the FDA product code for device for home collection and transport of specimens by lay users for use in a cleared non-viral sti molecular assay. It is a Class II device, regulated under 21 CFR 866.2920 and reviewed by the Microbiology panel. Devices under SIH reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| 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 |
| Regulation | 21 CFR 866.2920 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for SIH devices
openFDA lists no recalls for product code SIH.
Frequently asked questions
What is FDA product code SIH?
SIH is the FDA product code for device for home collection and transport of specimens by lay users for use in a cleared non-viral sti molecular assay. It is a Class II device, regulated under 21 CFR 866.2920 and reviewed by the Microbiology panel.
What device class is SIH?
Class II, regulation 21 CFR 866.2920. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SIH
- Run a recall and safety report across every SIH manufacturer
- Watch product code SIH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.