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 c
| Company | Devices | Share |
|---|---|---|
| Calibrescientific Us, Inc. | 54 | 62% |
| Enterix Inc. | 5 | 6% |
| Home Access Health Corporation | 4 | 5% |
| Immunostics Company, Inc | 4 | 5% |
| Exact Sciences Corporation | 3 | 3% |
| Ditek Consulting, Llc | 2 | 2% |
| Geneoscopy, Inc. | 2 | 2% |
| Privapath Diagnostics Limited | 2 | 2% |
| Cue Health Inc. | 2 | 2% |
| Quidel Corporation | 2 | 2% |
| Bühlmann Laboratories Ag | 1 | 1% |
| Blackfly Investments, Llc | 1 | 1% |
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 |
|---|---|---|
| LDZ | Fixative, Alcohol Containing | 32 |
| JSJ | Culture Media, Selective And Non-Differential | 11 |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | 8 |
| KHE | REAGENT, OCCULT BLOOD | 7 |
| KHE | Reagent, Occult Blood | 6 |
| IGB | Solution, Formalin-Sodium Acetate | 5 |
Use these as the dimensions to specify in a tender line.
87 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Faecal specimen collection kit IVD, home-use", from 17 companies. The largest labeler is Calibrescientific Us, Inc. with 62% of records.
LDZ (Fixative, Alcohol Containing), JSJ (Culture Media, Selective And Non-Differential), NNK (Container, Specimen Mailer And Storage, Non-Sterile), 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.