FDA.reportPublic FDA data

Faecal specimen collection kit IVD, home-use

Definition
A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.
GUDID devices
72
Last updated
2026-08-18 06:11:25

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810111410861LetsGetChecked Stool Sample Collection Kit (FCIT)PRIVAPATH DIAGNOSTICS LIMITEDFT01S2026-08-07
00850024881259LetsGetChecked Stool Sample Collection Kit (FCIT)PRIVAPATH DIAGNOSTICS LIMITEDFT01S2022-05-04
00304040002568Henry ScheinHENRY SCHEIN, INC.90044162016-09-24
00816085021324Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085021331Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085021348Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085021355Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-09
00816085021386Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022154Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022178Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022314PVA (Zn) Fix/10% Formalin 25 setsAlpha-TEC Systems, Inc.12022-07-20
00816085022338Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022352Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022369Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022567Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022628Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085023670Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00850057859096Cologuard ® Collection KitEXACT SCIENCES CORPORATION1009262026-04-22
00850093003316InSure® ONE™ENTERIX INC.012018-01-05
10722355001101hema-screen SPECIFICImmunostics Company, IncHSSPENV-202016-09-21
10722355003068hema-screen SPECIFIC GOLDImmunostics Company, IncHSGDENV-202025-04-16
10809160023754Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.753072016-08-20
10885380174155Aero-MedAERO-MED, LLCCA11425A2019-07-22
10885380177019Aero-MedAERO-MED, LLCCA267752020-02-04
00860009064317ColoSense Collection KitGeneoscopy, Inc.12025-09-25
00860013899295Colofit Test KitDitek Consulting, LLCDTCF012025-05-06
00858637005949The Cologuard Plus Collection KitEXACT SCIENCES CORPORATION1006762025-03-19
G7326001Everlywell FIT KitEverly Health, Inc.02025-02-14
00198715728941ColoSense Collection KitGeneoscopy, Inc.02024-07-30
00810040820977Colon Cancer Screening TestCue Health Inc.C22352024-02-12
EBUHBCALSAMPLER250Simple Sampler Stool Collection SetBühlmann Laboratories AGB-CAL-SAMPLER252023-06-26
00860008357861Molecular Testing LabsBlackfly Investments, LLC1.02023-03-29
00810040820618Cue Sample Collection Kit Cue Health Inc.C22412023-02-27
00816085021393Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085021478Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085022376Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085022444Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085022468Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085022499Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085022512Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085023663Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085021300Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085021430Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085021447Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085021454Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085021461Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085021485Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085022123Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022161Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022185Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022192Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022253Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022260Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085022277Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085022284Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022307Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022451Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085022475Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085022482Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085022550Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022574Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022635Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085022666Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022673Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085022680Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022703Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022826Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022833Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022840Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022857Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085022437Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11