A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).
| Company | Devices | Share |
|---|---|---|
| Polymedco Cancer Diagnostic Products Llc | 732 | 93% |
| Exact Sciences Corporation | 15 | 2% |
| Propper Manufacturing Company, Inc. | 14 | 2% |
| Immunostics Company, Inc | 5 | 1% |
| Enterix Inc. | 4 | 1% |
| Princeton Biomeditech Corporation | 3 | 0% |
| Prestige Ameritech, Ltd. | 2 | 0% |
| Cambridge Diagnostic Products Inc | 2 | 0% |
| Henry Schein, Inc. | 2 | 0% |
| Boditech Med Inc. | 2 | 0% |
| Hangzhou Alltest Biotech Co., Ltd. | 1 | 0% |
| Epitope Diagnostics Inc | 1 | 0% |
Company = labeler of record on GUDID. 17 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 |
|---|---|---|
| OOX | Automated Occult Blood Analyzer | 736 |
| KHE | Reagent, Occult Blood | 27 |
| PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin | 17 |
| KHE | REAGENT, OCCULT BLOOD | 7 |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | 1 |
| GGG | Guaiac Reagent | 1 |
Use these as the dimensions to specify in a tender line.
788 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Faecal occult blood IVD, reagent", from 17 companies. The largest labeler is Polymedco Cancer Diagnostic Products Llc with 93% of records.
OOX (Automated Occult Blood Analyzer), KHE (Reagent, Occult Blood), PHP (System, Colorectal Neoplasia, Dna Methylation And Hemoglobin), 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.