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Data / Medical devices / System, Test, Vitamin D / United States

FDA-registered makers of System, Test, Vitamin D in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make System, Test, Vitamin D (product code MRG). 9 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
System, Test, Vitamin D
Product code
MRG
Country
United States

Makers of System, Test, Vitamin D in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Diasorin Inc.Stillwater, MN, United StatesManufacturer3December 10, 2014050api.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
Diazyme Laboratories, Inc.Poway, CA, United StatesManufacturer1January 11, 2018000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1February 15, 2013000api.fda.gov
Qualigen, Inc.Carlsbad, CA, United StatesManufacturer1July 3, 2013020api.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
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 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.