Data / Medical devices / General Purpose Reagent / United States

FDA-registered makers of General Purpose Reagent in the United States: 119 establishments

Name: FDA-registered makers of General Purpose Reagent in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

119 establishments in the United States are registered with the FDA to make General Purpose Reagent (product code PPM). 0 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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Device: General Purpose Reagent
Product code: PPM
Country: United States

Makers of General Purpose Reagent in the United States

Maker	Location	Role	Recall events	Class I	Source
Abbott Laboratories	Irving, TX, United States	Specification developer	0	0	api.fda.gov
Abbott Molecular, Inc.	Des Plaines, IL, United States	Manufacturer, Manufacturer for export, Specification developer	0	0	api.fda.gov
Agena Bioscience Incorporated	San Diego, CA, United States	Manufacturer	0	0	api.fda.gov
American Red Cross Diagnostic Manufacturing Divisi	Gaithersburg, MD, United States	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Analytichem Usa, Inc.	Winslow, ME, United States	Manufacturer	0	0	api.fda.gov
Antibodies Incorporated	Davis, CA, United States	Contract manufacturer	0	0	api.fda.gov
Asuragen, Inc.	Austin, TX, United States	Manufacturer	0	0	api.fda.gov
Axiom Diagnostics, Inc.	Tampa, FL, United States	Manufacturer	0	0	api.fda.gov
Azer Scientific, Inc.	Morgantown, PA, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0	0	api.fda.gov
Abbott Molecular Distribution Center	Itasca, IL, United States	Manufacturer	0	0	api.fda.gov
Advanced Cell Diagnostics, Inc.	Newark, CA, United States	Contract manufacturer	0	0	api.fda.gov
Agilent Technologies Inc.	Cedar Creek, TX, United States	Complaint file establishment, Manufacturer	0	0	api.fda.gov
Agilent Technologies, Inc	Santa Clara, CA, United States	Specification developer	1	0	api.fda.gov
Agilent Technologies, Inc.	Carpinteria, CA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Alere San Diego, Inc.	Pomona, CA, United States	Manufacturer, Manufacturer for export	0	0	api.fda.gov
American Laboratory Products Company	Salem, NH, United States	Manufacturer	0	0	api.fda.gov
Baebies Inc.	Durham, NC, United States	Contract manufacturer	0	0	api.fda.gov
Beckman Coulter, Inc.	Brea, CA, United States	Specification developer	0	0	api.fda.gov
Beckman Coulter, Inc.	Chaska, MN, United States	Manufacturer	1	0	api.fda.gov
Beckman Coulter, Inc.	Carlsbad, CA, United States	Contract manufacturer	0	0	api.fda.gov
Beckman Coulter, Inc.	Hialeah, FL, United States	Contract manufacturer	0	0	api.fda.gov
Beckman Coulter, Inc.	Miami, FL, United States	Specification developer	0	0	api.fda.gov
Becton, Dickinson & Co.	Sparks, MD, United States	Complaint file establishment, Manufacturer, Specification developer	1	0	api.fda.gov
Becton, Dickinson & Co.	Cockeysville, MD, United States	Manufacturer	0	0	api.fda.gov
Bio SB, Inc.	Santa Barbara, CA, United States	Manufacturer, Remanufacturer, Repackager or relabeler	0	0	api.fda.gov
Biocare Medical, LLC	Pacheco, CA, United States	Manufacturer, Repackager or relabeler	1	0	api.fda.gov
Biogenex Laboratories Inc.	Fremont, CA, United States	Manufacturer	0	0	api.fda.gov
Bion Enterprises, Ltd.	Des Plaines, IL, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Beckman Coulter, Inc.	Hebron, KY, United States	Contract manufacturer	0	0	api.fda.gov
Becton Dickinson Caribe, LTD	Cayey, PR, United States	Contract manufacturer	0	0	api.fda.gov
Becton, Dickinson and Company	Mebane, NC, United States	Manufacturer	0	0	api.fda.gov
Becton, Dickinson and Company, BD Biosciences	Milpitas, CA, United States	Complaint file establishment, Specification developer	0	0	api.fda.gov
Calbiotech, Inc.	El Cajon, CA, United States	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Cambridge Diagnostic Products, Inc.	Fort Lauderdale, FL, United States	Manufacturer	0	0	api.fda.gov
Cell Marque Corp.	Saint Louis, MO, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Cell Marque Corp.	Rocklin, CA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Cellsolutions LLC	Greensboro, NC, United States	Complaint file establishment, Specification developer	0	0	api.fda.gov
Clinical Diagnostic Solutions, Inc.	Plantation, FL, United States	Manufacturer	0	0	api.fda.gov
Cliniqa Corporation	San Marcos, CA, United States	Manufacturer	0	0	api.fda.gov
Copan Diagnostics, Inc.	Murrieta, CA, United States	Manufacturer	0	0	api.fda.gov
COPAN Diagnostics, Inc.	Carlsbad, CA, United States	Manufacturer	0	0	api.fda.gov
Covaris, LLC	Woburn, MA, United States	Manufacturer	0	0	api.fda.gov
CTK Biotech, Inc.	Poway, CA, United States	Manufacturer	0	0	api.fda.gov
CalibreScientific US, Inc.	Vancouver, WA, United States	Manufacturer	0	0	api.fda.gov
Cancer Diagnostics, Inc.	Durham, NC, United States	Manufacturer	0	0	api.fda.gov
CareDx, Inc.	Brisbane, CA, United States	Specification developer	0	0	api.fda.gov
Cellay, Inc.	Cambridge, MA, United States	Manufacturer, Repackager or relabeler, Specification developer	0	0	api.fda.gov
CytoTest, Inc.	Rockville, MD, United States	Manufacturer	0	0	api.fda.gov
Diagnostic Biosystems	Pleasanton, CA, United States	Manufacturer	0	0	api.fda.gov
DSRV, Inc.	Mount Olive, NJ, United States	Contract manufacturer	0	0	api.fda.gov
Dxterity Diagnostics Inc.	Torrance, CA, United States	Complaint file establishment, Specification developer	0	0	api.fda.gov
DiaSorin Molecular LLC	Cypress, CA, United States	Manufacturer	0	0	api.fda.gov
E K Industries, Inc.	Joliet, IL, United States	Manufacturer	0	0	api.fda.gov
ELITechGroup Inc	Logan, UT, United States	Contract manufacturer	0	0	api.fda.gov
ELITechGroup MDX LLC.	Bothell, WA, United States	Manufacturer	0	0	api.fda.gov
Empirical Bioscience	Grand Rapids, MI, United States	Complaint file establishment, Manufacturer	0	0	api.fda.gov
Epitope Diagnostics, Inc.	San Diego, CA, United States	Manufacturer	0	0	api.fda.gov
Ethos Biosciences, INC.	Logan Township, NJ, United States	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Exact Sciences Corporation- Discovery Campus	Madison, WI, United States	Manufacturer	0	0	api.fda.gov
Exact Sciences Corporation- Innovation Campus	Madison, WI, United States	Manufacturer	0	0	api.fda.gov
Fertility Solutions, Inc.	Warrensville Heights, OH, United States	Manufacturer	0	0	api.fda.gov
Fisher Diagnostics	Middletown, VA, United States	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Gold Standard Diagnostics, LLC	Davis, CA, United States	Repackager or relabeler, Specification developer	0	0	api.fda.gov
Grifols Diagnostic Solutions Inc.	San Diego, CA, United States	Manufacturer	0	0	api.fda.gov
Haemonetics Corporation	Boston, MA, United States	Specification developer	0	0	api.fda.gov
Hardy Diagnostics	Orcutt, CA, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Hemagen Diagnostics, Inc.	Baltimore, MD, United States	Manufacturer	0	0	api.fda.gov
Haemonetics Corporation	Clinton, PA, United States	Manufacturer, Manufacturer for export	0	0	api.fda.gov
Hardy Diagnostics	Springboro, OH, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
HealthBio, Inc	Hayward, CA, United States	Complaint file establishment, Manufacturer	0	0	api.fda.gov
High Technology, Inc.	North Attleboro, MA, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Hologic, Inc.	San Diego, CA, United States	Manufacturer, Manufacturer for export	0	0	api.fda.gov
IMMY, Inc.	Norman, OK, United States	Manufacturer	1	0	api.fda.gov
Inova Diagnostics, Inc.	San Diego, CA, United States	Manufacturer	0	0	api.fda.gov
Immucor GTI Diagnostics, Inc.	Waukesha, WI, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Infrared Laboratory Systems dba SYNERMED	Westfield, IN, United States	Contract manufacturer	0	0	api.fda.gov
Invivoscribe, Inc.	San Diego, CA, United States	Complaint file establishment, Manufacturer	0	0	api.fda.gov
Labone, Inc.	Lenexa, KS, United States	Manufacturer	0	0	api.fda.gov
LGM International Inc.	Melbourne, FL, United States	Manufacturer	0	0	api.fda.gov
Life Technologies Corporation	Austin, TX, United States	Manufacturer	0	0	api.fda.gov
Lifecycle Biotechnologies, LLC	Cleburne, TX, United States	Manufacturer	0	0	api.fda.gov
Lonza Walkersville, Inc.	Walkersville, MD, United States	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Lumatas Biosystems, Inc	Milpitas, CA, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Leica Biosystems Richmond, Inc.	Richmond, IL, United States	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Life Technologies Corporation	Frederick, MD, United States	Manufacturer	0	0	api.fda.gov
Medical Chemical Corporation	Torrance, CA, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Microbiologics, Inc.	Saint Cloud, MN, United States	Manufacturer	0	0	api.fda.gov
ML LifeSciences	Irvine, CA, United States	Contract manufacturer, Contract sterilizer, Manufacturer	0	0	api.fda.gov
Newcomer Supply Inc	Waunakee, WI, United States	Specification developer	0	0	api.fda.gov
Novodiax, Inc.	Hayward, CA, United States	Manufacturer	0	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Manufacturer	0	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Complaint file establishment, Specification developer	2	0	api.fda.gov
Phoenix Diagnostics, Inc.	Natick, MA, United States	Manufacturer	0	0	api.fda.gov
Promega Corporation	Madison, WI, United States	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Qiagen	Germantown, MD, United States	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Remel, Inc.	Lenexa, KS, United States	Manufacturer, Specification developer	0	0	api.fda.gov
Ricca Chemical Company LLC	Pocomoke City, MD, United States	Manufacturer	0	0	api.fda.gov
Ricca Chemical Company LLC	Arlington, TX, United States	Manufacturer	0	0	api.fda.gov
Ricca Chemical Company LLC	Batesville, IN, United States	Manufacturer	0	0	api.fda.gov
Richard-Allan Scientific LLC	Kalamazoo, MI, United States	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Roche Molecular Systems, Inc.	Branchburg, NJ, United States	Manufacturer, Manufacturer for export	0	0	api.fda.gov
Roche Molecular Systems, Inc.	Pleasanton, CA, United States	Specification developer	0	0	api.fda.gov
Sakura Finetek U.s.a., Inc.	Torrance, CA, United States	Manufacturer	0	0	api.fda.gov
Sarstedt, Inc.	Newton, NC, United States	Manufacturer	0	0	api.fda.gov
Scytek Laboratories, Inc.	Logan, UT, United States	Manufacturer	0	0	api.fda.gov
Sigma-Aldrich Manufacturing, LLC	St. Louis, MO, United States	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Sigma-Aldrich Manufacturing, LLC-H&H	Saint Louis, MO, United States	Manufacturer	0	0	api.fda.gov
SLMP LLC d.b.a. StatLab Medical Products	McKinney, TX, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
STS Corporation	Duluth, GA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, United States	Complaint file establishment, Specification developer	0	0	api.fda.gov
Sun Diagnostics, LLC	New Gloucester, ME, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Truckee Applied Genomics Inc	Reno, NV, United States	Manufacturer	0	0	api.fda.gov
Takara Bio USA, Inc.	San Jose, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0	0	api.fda.gov
Ventana Medical Systems, Inc.	Tucson, AZ, United States	Manufacturer, Manufacturer for export, Specification developer	2	2	api.fda.gov
Vision Diagnostics Inc.	Branford, FL, United States	Manufacturer	0	0	api.fda.gov
Volusol	Tooele, UT, United States	Manufacturer	0	0	api.fda.gov
VWR Chemicals, LLC	Solon, OH, United States	Contract manufacturer	0	0	api.fda.gov
Wavesense, Inc.	Irvine, CA, United States	Manufacturer	0	0	api.fda.gov
Zeus Scientific LLC	Branchburg, NJ, United States	Manufacturer, Repackager or relabeler	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.