A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class II antigens in a clinical specimen, using a multiplex method.
| Company | Devices | Share |
|---|---|---|
| Caredx Ab | 54 | 96% |
| Immucor Gti Diagnostics, Inc. | 2 | 4% |
Company = labeler of record on GUDID. 2 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 |
|---|---|---|
| MZI | Test,Qualitative,For Hla,Non-Diagnostic | 3 |
| MZI | Test, Qualitative, For Hla, Non-Diagnostic | 1 |
Use these as the dimensions to specify in a tender line.
56 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "HLA class II antigen tissue typing IVD, kit, multiplex", from 2 companies. The largest labeler is Caredx Ab with 96% of records.
MZI (Test,Qualitative,For Hla,Non-Diagnostic), MZI (Test, Qualitative, For Hla, Non-Diagnostic)
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.