Data / Medical devices / Test, Qualitative, For Hla, Non-Diagnostic / United States
FDA-registered makers of Test, Qualitative, For Hla, Non-Diagnostic in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Test, Qualitative, For Hla, Non-Diagnostic (product code MZI). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Test, Qualitative, For Hla, Non-Diagnostic
- Product code
- MZI
- Country
- United States
Makers of Test, Qualitative, For Hla, Non-Diagnostic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bioarray Solutions Limited | Warren, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson Caribe, LTD | Cayey, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson and Company, BD Biosciences | Milpitas, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immucor GTI Diagnostics, Inc. | Waukesha, WI, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| One Lambda, Inc. | West Hills, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.