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 I and II antigens in a clinical specimen, using a multiplex method.
| Company | Devices | Share |
|---|---|---|
| One Lambda, Inc. | 328 | 98% |
| Caredx Ab | 3 | 1% |
| Immucor Gti Diagnostics, Inc. | 2 | 1% |
Company = labeler of record on GUDID. 3 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 | 323 |
| QUK | Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Te | 3 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 2 |
| MZI | Test, Qualitative, For Hla, Non-Diagnostic | 1 |
Use these as the dimensions to specify in a tender line.
333 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "HLA class I & II antigen tissue typing IVD, kit, multiplex", from 3 companies. The largest labeler is One Lambda, Inc. with 98% of records.
MZI (Test,Qualitative,For Hla,Non-Diagnostic), QUK (Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Te), NSU (Instrumentation For Clinical Multiplex Test Systems), 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.