Data / Medical devices / Single (Specified) Analyte Controls (Assayed And Unassayed) / Germany
FDA-registered makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in Germany: 10 establishments
10 establishments in Germany are registered with the FDA to make Single (Specified) Analyte Controls (Assayed And Unassayed) (product code JJX). 4 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
- Single (Specified) Analyte Controls (Assayed And Unassayed)
- Product code
- JJX
- Country
- Germany
Makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 5 | April 4, 2017 | 0 | 0 | 0 | api.fda.gov |
| ABBOTT GmbH | Wiesbaden Hesse, Germany | Exporter to the US, Manufacturer, Specification developer | 3 | October 26, 2016 | 0 | 0 | 0 | api.fda.gov |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Contract manufacturer, Manufacturer | 1 | September 6, 2011 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 1 | October 18, 2001 | 0 | 0 | 0 | api.fda.gov |
| B.R.A.H.M.S GmbH | HENNIGSDORF Brandenburg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chromsystems Instruments & Chemicals GMBH | Gräfelfing Bavaria, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diasys Diagnostic Systems GMBH | Holzheim Rhineland-Palatinate, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DiaSorin Deutschland GmbH | Dietzenbach Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ibl International GMBH | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Specification developer | 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.