SIHClass II

Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay

21 CFR 866.2920 / Microbiology

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, a class II device type, regulated under 21 CFR 866.2920. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2026-06-10, and no recalls.

Classification record

Product code: SIH
Device name: Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay
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.
Regulation: 21 CFR 866.2920
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code SIH

By decision year

1 clearance under product code SIH with a decision year between 2026 and 2026, 2026 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code SIH by decision year
Year	Clearances
2026	1

Applicants with the most clearances

Product code SIH

Applicants holding the most 510(k) clearances under product code SIH
Applicant	Clearances
DNA Genotek Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code SIH

K254121Class IIColli-Pee•Dx Urine Collection KitDNA Genotek, Inc. / cleared 2026-06-10

Recent recalls

Product code SIH

FDA records show no recalls under product code SIH.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)