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) within a short period relative to standard laboratory testing procedures, usin
| Company | Devices | Share |
|---|---|---|
| Helena Laboratories Corporation | 24 | 24% |
| Immunostics Company, Inc | 15 | 15% |
| Fisher Scientific Company L.L.C. | 12 | 12% |
| Beckman Coulter, Inc. | 12 | 12% |
| Prestige Ameritech, Ltd. | 9 | 9% |
| Mckesson Medical-Surgical Inc. | 9 | 9% |
| Henry Schein, Inc. | 4 | 4% |
| Germaine Laboratories, Inc | 3 | 3% |
| Cenogenics Corporation | 3 | 3% |
| Siemens Healthcare Diagnostics Inc. | 2 | 2% |
| Biomerica, Inc. | 2 | 2% |
| National Distribution & Contracting, Inc. | 2 | 2% |
Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| KHE | REAGENT, OCCULT BLOOD | 57 |
| KHE | Reagent, Occult Blood | 45 |
Use these as the dimensions to specify in a tender line.
100 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 colorimetric, clinical", from 15 companies. The largest labeler is Helena Laboratories Corporation with 24% of records.
KHE (REAGENT, OCCULT BLOOD), KHE (Reagent, Occult Blood)
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.