Consulting Wallah › Device Explorer › IVD & laboratory › Faecal occult blood IVD, kit, rapid ICT, clinical
Device Explorer · FDA GUDID · GMDN 54532

Faecal occult blood IVD, kit, rapid ICT, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin) within a short period, relative to standard laboratory test

US‑registered devices175in commercial distribution
Companies28labelers on GUDID
Single‑use96%of device records
Sterile0%labelled sterile
Prescription45%Rx‑only share
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Share of device records

Polymedco Cancer Diagnostic Products Llc5833%
Hemosure Inc.1710%
Mckesson Medical-Surgical Inc.127%
Alfa Scientific Designs, Inc.85%
Wondfo Usa Co., Ltd.74%
Germaine Laboratories, Inc74%
Henry Schein, Inc.63%
Immunostics Company, Inc63%

Top labelers

CompanyDevicesShare
Polymedco Cancer Diagnostic Products Llc5833%
Hemosure Inc.1710%
Mckesson Medical-Surgical Inc.127%
Alfa Scientific Designs, Inc.85%
Wondfo Usa Co., Ltd.74%
Germaine Laboratories, Inc74%
Henry Schein, Inc.63%
Immunostics Company, Inc63%
Medline Industries, Inc.53%
Beckman Coulter, Inc.53%
Jant Pharmacal Corporation53%
Enterix Inc.42%

Company = labeler of record on GUDID. 28 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Fluoro-CheckTM iFOBMD DrugScreenHEMOSURE®OC-Light SInSure® ONE™InSure FITQMedix™Red TunicaTanner Scientific®ClarityHemosure® Accu-Reader®WELLlife™PreviewHealgenGenaCheck Rapid Self-Test Kit for FOBForSure iFOB Test (buffer only)

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KHEReagent, Occult Blood167
KHEREAGENT, OCCULT BLOOD24

GMDN & GCC registration

  • GMDN code 54532 · non‑implantable
  • Single‑use 96% · sterile 0% · Rx‑only 45% · OTC 7%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many faecal occult blood ivd, kit, rapid ict, clinical products are registered in the US?

175 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Faecal occult blood IVD, kit, rapid ICT, clinical", from 28 companies. The largest labeler is Polymedco Cancer Diagnostic Products Llc with 33% of records.

Which FDA product codes apply?

KHE (Reagent, Occult Blood), KHE (REAGENT, OCCULT BLOOD)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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