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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

CountryMakers
United States20
Germany4
United Kingdom2
France2
Ireland2
South Korea2
Japan1
Belgium1
China1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Immunodiagnostic Systems Ltd.Boldon Colliery Durham, United KingdomManufacturer8November 15, 2016000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesManufacturer3December 10, 2014050api.fda.gov
Immunotech SAS, a Beckman Coulter companyMARSEILLE, CEDEX 9 Bouches-du-Rhone, FranceSpecification developer3January 19, 2023000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler3September 1, 2021000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer3May 29, 2020000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesComplaint file establishment, Specification developer2June 22, 2018000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer2July 24, 2014040api.fda.gov
Tosoh Aia, Inc.Toyama, JapanManufacturer2October 26, 2015000api.fda.gov
Abbott Ireland Diagnostics DivisionLongford, IrelandManufacturer1August 12, 2016010api.fda.gov
DRG Instruments GMBHMARBURG Hesse, GermanyComplaint file establishment, Manufacturer1July 15, 2013000api.fda.gov
DiaSource ImmunoAssays, SALouvain-La-Neuve Brabant Wallon, BelgiumManufacturer1July 15, 2013000api.fda.gov
Diazyme Laboratories, Inc.Poway, CA, United StatesManufacturer1January 11, 2018000api.fda.gov
Euroimmun Medizinische Labordiagnostika AGLuebeck Schleswig-Holstein, GermanyManufacturer1July 17, 2013000api.fda.gov
EUROIMMUN Medizinische Labordiagnostika AGDassow Mecklenburg-Western Pomerania, GermanyManufacturer1July 17, 2013000api.fda.gov
Immunodiagnostic Systems France SASPOUILLY EN AUXOIS Cote-d'Or, FranceManufacturer1November 15, 2016000api.fda.gov
Nanoentek IncHwaseong Gyeonggi, South KoreaManufacturer1January 12, 2017000api.fda.gov
Nanoentek IncSeoul, South KoreaSpecification developer1January 12, 2017000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1February 15, 2013000api.fda.gov
Ortho-Clinical DiagnosticsPencoed Bridgend, United KingdomManufacturer1February 15, 2013000api.fda.gov
Qualigen, Inc.Carlsbad, CA, United StatesManufacturer1July 3, 2013020api.fda.gov
Shenzhen New Industries Biomedical Engineering Co.,ltdShenzhen Guangdong, ChinaManufacturer1April 12, 2024000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer1March 16, 2017000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesManufacturer, Manufacturer for export1May 29, 2020000api.fda.gov
Affimedix, Inc.Hayward, CA, United StatesManufacturer for export0000api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesContract manufacturer0000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer for export0000api.fda.gov
Bio-Rad Laboratories, Inc.Woodinville, WA, United StatesContract manufacturer0000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandContract manufacturer0000api.fda.gov
CTK Biotech, Inc.Poway, CA, United StatesManufacturer for export0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov
Immunocentrix CorporationCanoga Park, CA, United StatesManufacturer for export0000api.fda.gov
Immunostics, Inc.Eatontown, NJ, United StatesManufacturer for export0000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer for export0000api.fda.gov
Nano-Ditech CorporationCranbury, NJ, United StatesManufacturer for export0000api.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.