Data / Medical devices / Multi-Analyte Controls, All Kinds (Assayed) / United Kingdom
FDA-registered makers of Multi-Analyte Controls, All Kinds (Assayed) in the United Kingdom: 7 establishments
7 establishments in the United Kingdom are registered with the FDA to make Multi-Analyte Controls, All Kinds (Assayed) (product code JJY). 3 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
- Multi-Analyte Controls, All Kinds (Assayed)
- Product code
- JJY
- Country
- United Kingdom
Makers of Multi-Analyte Controls, All Kinds (Assayed) 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 | 19 | December 8, 2014 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 3 | November 4, 1998 | 0 | 0 | 0 | api.fda.gov |
| Randox Laboratories Limited | ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | September 9, 2004 | 0 | 0 | 0 | api.fda.gov |
| Axis-Shield Diagnostics, Ltd. | DUNDEE Scotland, United Kingdom | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Binding Site | Kings Norton Birmingham, United Kingdom | Complaint file establishment, 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.