DeviceClearance

Product code SIH— Microbiology

Colli-PeeDx Urine Collection Kit

Classification 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 2
Regulation
21 CFR 866.2920
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SIH under 21 CFR 866.2920, via openFDA

Market context for product code SIH

FDA has cleared 1 device under product code SIH, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SIH

Recent clearances under product code SIH

Data sourced from openFDA. This site is unofficial and independent of the FDA.