Data / Medical devices / System, Test, Vitamin D
System, Test, Vitamin D (MRG): 35 FDA-registered makers in 9 countries
35 establishments in 9 countries are registered with the FDA to make System, Test, Vitamin D (product code MRG, Class 2, 21 CFR 862.1825). 23 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 46 510(k) clearances under this code, the latest on April 12, 2024, and lists 19 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MRG
- Device class
- 2
- Regulation
- 862.1825
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 20 |
| Germany | 4 |
| United Kingdom | 2 |
| France | 2 |
| Ireland | 2 |
| South Korea | 2 |
| Japan | 1 |
| Belgium | 1 |
| China | 1 |
Makers of System, Test, Vitamin D
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Immunodiagnostic Systems Ltd. | Boldon Colliery Durham, United Kingdom | Manufacturer | 8 | November 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer | 3 | December 10, 2014 | 0 | 5 | 0 | api.fda.gov |
| Immunotech SAS, a Beckman Coulter company | MARSEILLE, CEDEX 9 Bouches-du-Rhone, France | Specification developer | 3 | January 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 3 | September 1, 2021 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 3 | May 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 2 | June 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 2 | July 24, 2014 | 0 | 4 | 0 | api.fda.gov |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 2 | October 26, 2015 | 0 | 0 | 0 | api.fda.gov |
| Abbott Ireland Diagnostics Division | Longford, Ireland | Manufacturer | 1 | August 12, 2016 | 0 | 1 | 0 | api.fda.gov |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 1 | July 15, 2013 | 0 | 0 | 0 | api.fda.gov |
| DiaSource ImmunoAssays, SA | Louvain-La-Neuve Brabant Wallon, Belgium | Manufacturer | 1 | July 15, 2013 | 0 | 0 | 0 | api.fda.gov |
| Diazyme Laboratories, Inc. | Poway, CA, United States | Manufacturer | 1 | January 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 1 | July 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 1 | July 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Immunodiagnostic Systems France SAS | POUILLY EN AUXOIS Cote-d'Or, France | Manufacturer | 1 | November 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| Nanoentek Inc | Hwaseong Gyeonggi, South Korea | Manufacturer | 1 | January 12, 2017 | 0 | 0 | 0 | api.fda.gov |
| Nanoentek Inc | Seoul, South Korea | Specification developer | 1 | January 12, 2017 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | February 15, 2013 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 1 | February 15, 2013 | 0 | 0 | 0 | api.fda.gov |
| Qualigen, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | July 3, 2013 | 0 | 2 | 0 | api.fda.gov |
| Shenzhen New Industries Biomedical Engineering Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 1 | April 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | March 16, 2017 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Manufacturer, Manufacturer for export | 1 | May 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Affimedix, Inc. | Hayward, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Chaska, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunostics, Inc. | Eatontown, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nano-Ditech Corporation | Cranbury, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 12, 2024. 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.