Data / Medical devices / Calibrator, Multi-Analyte Mixture / United Kingdom
FDA-registered makers of Calibrator, Multi-Analyte Mixture in the United Kingdom: 7 establishments
7 establishments in the United Kingdom are registered with the FDA to make Calibrator, Multi-Analyte Mixture (product code JIX). 1 has 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
- Calibrator, Multi-Analyte Mixture
- Product code
- JIX
- Country
- United Kingdom
Makers of Calibrator, Multi-Analyte Mixture in the United Kingdom
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer, Manufacturer, Repackager or relabeler | 5 | February 18, 2011 | 0 | 0 | 0 | api.fda.gov |
| Axis-Shield Diagnostics, Ltd. | DUNDEE Scotland, United Kingdom | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories Limited | ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Manufacturing Ltd | SUDBURY Suffolk, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Binding Site | Kings Norton Birmingham, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Binding Site Group Ltd. | Birmingham, United Kingdom | Complaint file establishment, Manufacturer | 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.