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Data / Medical devices / Reagents, Specific, Analyte / United States

FDA-registered makers of Reagents, Specific, Analyte in the United States: 59 establishments

59 establishments in the United States are registered with the FDA to make Reagents, Specific, Analyte (product code MVU). 0 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
Reagents, Specific, Analyte
Product code
MVU
Country
United States

Makers of Reagents, Specific, Analyte in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Abbott Molecular, Inc.Des Plaines, IL, United StatesManufacturer, Specification developer0030api.fda.gov
Antibodies IncorporatedDavis, CA, United StatesContract manufacturer0000api.fda.gov
Advanced Cell Diagnostics, Inc.Newark, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Agilent Technologies Inc.Cedar Creek, TX, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Agilent Technologies, IncSanta Clara, CA, United StatesSpecification developer0000api.fda.gov
Agilent Technologies, Inc.Carpinteria, CA, United StatesManufacturer0000api.fda.gov
Alere San Diego, Inc.Pomona, CA, United StatesManufacturer0000api.fda.gov
Applied BioCode, Inc.Santa Fe Springs, CA, United StatesManufacturer0000api.fda.gov
Baebies Inc.Durham, NC, United StatesContract manufacturer0000api.fda.gov
BD Biosciences San DiegoSan Diego, CA, United StatesSpecification developer0000api.fda.gov
Beckman Coulter, Inc.Hialeah, FL, United StatesContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Miami, FL, United StatesSpecification developer0000api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bio SB, Inc.Santa Barbara, CA, United StatesContract manufacturer, Manufacturer, Remanufacturer0000api.fda.gov
Biocare Medical, LLCPacheco, CA, United StatesManufacturer0000api.fda.gov
Biogenex Laboratories Inc.Fremont, CA, United StatesManufacturer0010api.fda.gov
Biolegend, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Becton Dickinson Caribe, LTDCayey, PR, United StatesContract manufacturer0000api.fda.gov
Becton, Dickinson and Company, BD BiosciencesMilpitas, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Calbiotech, Inc.El Cajon, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Caprico Biotechnologies, Inc.Duluth, GA, United StatesManufacturer0000api.fda.gov
Cell Marque Corp.Saint Louis, MO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Cell Marque Corp.Rocklin, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0020api.fda.gov
CalibreScientific US, Inc.Vancouver, WA, United StatesManufacturer0000api.fda.gov
Cellay, Inc.Cambridge, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
CytoTest, Inc.Rockville, MD, United StatesManufacturer0000api.fda.gov
Diagnostic BiosystemsPleasanton, CA, United StatesManufacturer0000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
DiaSorin Molecular LLCCypress, CA, United StatesManufacturer0000api.fda.gov
ELITechGroup MDX LLC.Bothell, WA, United StatesManufacturer0000api.fda.gov
Empire Genomics Corp.Depew, NY, United StatesManufacturer0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Eurofins Genomics LLCLouisville, KY, United StatesManufacturer0000api.fda.gov
Fort Worth Diagnostics LLCFort Worth, TX, United StatesManufacturer0000api.fda.gov
Genzyme CoporationNorthborough, MA, United StatesManufacturer0000api.fda.gov
Hemo BioscienceDurham, NC, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Hycor BiomedicalGarden Grove, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
HealthBio, IncHayward, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Hologic, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Id-Fish Technology, IncMilpitas, CA, United StatesManufacturer0000api.fda.gov
Immco Diagnostics, Inc.Williamsville, NY, United StatesManufacturer0000api.fda.gov
IMMY, Inc.Norman, OK, United StatesManufacturer0000api.fda.gov
Inbios International, Inc.Seattle, WA, United StatesManufacturer0000api.fda.gov
Inova Diagnostics, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Integen LLCOrlando, FL, United StatesManufacturer0000api.fda.gov
Ikonisys, IncNew Haven, CT, United StatesManufacturer0000api.fda.gov
Invivoscribe, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
KBMO Diagnostics, LLC.Hopedale, MA, United StatesManufacturer0000api.fda.gov
Lee Laboratories, Inc.Grayson, GA, United StatesManufacturer0000api.fda.gov
Laboratory Corporation (LabCorp) of America HoldingsMorrisville, NC, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Life Technologies CorporationFrederick, MD, United StatesManufacturer0000api.fda.gov
Menarini Silicon Biosystems Inc.Huntingdon Valley, PA, United StatesManufacturer0000api.fda.gov
Novodiax, Inc.Hayward, CA, United StatesManufacturer0000api.fda.gov
QiagenGermantown, MD, United StatesManufacturer0000api.fda.gov
Rocky Mountain Reagents, Inc.Golden, CO, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Sakura Finetek U.s.a., Inc.Torrance, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Supertechs, Inc.Gaithersburg, MD, United StatesManufacturer0000api.fda.gov
Ventana Medical Systems, Inc.Tucson, AZ, United StatesManufacturer0000api.fda.gov
Zeta CorporationMonrovia, CA, United StatesManufacturer0000api.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.