A reagent which is intended to be used together with a parent IVD to perform a specific function in an assay that is used to evaluate a clinical specimen to diagnose or predict donor and recipient tissue compatibility based on one or multiple genetic markers f
| Company | Devices | Share |
|---|---|---|
| Orfit Industries Nv | 234 | 100% |
Company = labeler of record on GUDID. 1 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 |
|---|---|---|
| IYE | Accelerator, linear, medical | 233 |
| LWG | SURGICAL TABLE CUSHION | 1 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
234 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "DNA-based tissue typing IVD, reagent", from 1 companies. The largest labeler is Orfit Industries Nv with 100% of records.
IYE (Accelerator, linear, medical), LWG (SURGICAL TABLE CUSHION)
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.