Data / Medical devices / General Purpose Reagent

General Purpose Reagent (PPM): 224 FDA-registered makers in 23 countries

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

224 establishments in 23 countries are registered with the FDA to make General Purpose Reagent (product code PPM, Class 1, 21 CFR 864.4010). 0 of them have a 510(k) clearance or PMA approval on file and 11 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on April 29, 1987, and lists 23 recall events (3 Class I). FDA data exported November 2, 2026.

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Product code: PPM
Device class: 1
Regulation: 864.4010
Medical specialty: Pathology

Makers by country

Country	Makers
United States	119
China	27
Germany	15
United Kingdom	11
Japan	6
France	6
Italy	5
India	5
South Korea	4
Canada	4
Switzerland	3
Belgium	3
Denmark	2
Taiwan	2
Israel	2
Ireland	2
Sweden	2
Singapore	1
Poland	1
Hungary	1
Lithuania	1
Spain	1
Finland	1

Makers of General Purpose Reagent

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	Recall events	Class I	Source
5-Diagnostics	CH-4051 Basel Basel-Landschaft, Switzerland	Complaint file establishment, Exporter to the US, Manufacturer	0	0	api.fda.gov
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
Addax Biosciences SRL	Torino Piedmont, Italy	Manufacturer	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
Arkray, Inc.	Kamigyo-ku Kyoto, Japan	Specification developer	0	0	api.fda.gov
Asuragen, Inc.	Austin, TX, United States	Manufacturer	0	0	api.fda.gov
Aug. Hedinger GMBH & Co. KG	Stuttgart Baden-Wurttemberg, Germany	Contract manufacturer	0	0	api.fda.gov
Aurolab	MADURAI Tamil Nadu, India	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Autobio Diagnostics Co., Ltd.	Zhengzhou Henan, China	Manufacturer	0	0	api.fda.gov
Ave Science & Technology Co., Ltd	Changsha Hunan, China	Exporter to the US, 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 Denmark ApS	GLOSTRUP Hovedstaden, Denmark	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Agilent Technologies Inc.	Cedar Creek, TX, United States	Complaint file establishment, Manufacturer	0	0	api.fda.gov
Agilent Technologies Singapore (International) Pte Ltd.	Singapore North East, Singapore	Specification developer	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
Avantor Performance Materials Poland S.A.	Gliwice Slaskie, Poland	Contract manufacturer	0	0	api.fda.gov
B&e Bio-Technology Co., Ltd.	Yantai Shandong, China	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 Preventive Medicine Corp.	Zhubei City, Hsinchu(County), Taiwan	Complaint file establishment, 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
Biochrom Ltd	CAMBRIDGE Cambridgeshire, United Kingdom	Complaint file establishment, Manufacturer	0	0	api.fda.gov
Biogenex Laboratories Inc.	Fremont, CA, United States	Manufacturer	0	0	api.fda.gov
BIOMERIEUX SA - Grenoble	Grenoble Cedex 01 Auvergne-Rhone-Alpes, France	Manufacturer	1	0	api.fda.gov
Bion Enterprises, Ltd.	Des Plaines, IL, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Bioptic Inc.	New Taipei, Taiwan	Manufacturer	0	0	api.fda.gov
Bioteke Corporation (wuxi) Co., Ltd	Wuxi City Jiangsu, China	Manufacturer	0	0	api.fda.gov
Bioview Ltd.	REHOVOT Central, Israel	Manufacturer	0	0	api.fda.gov
Boen Healthcare Co., Ltd.	Suzhou Jiangsu, China	Exporter to the US, Specification developer	0	0	api.fda.gov
Buhlmann Laboratories AG	SCHONENBUCH/BASEL Basel-Landschaft, Switzerland	Manufacturer	0	0	api.fda.gov
Beckman Coulter GmbH	Krefeld North Rhine-Westphalia, Germany	Contract manufacturer	0	0	api.fda.gov
Beckman Coulter India Private Limited	Bengaluru (Bangalore) Urban Karnataka, India	Specification developer	0	0	api.fda.gov
Beckman Coulter Ireland Inc	O CALLAGHANS MILLS Clare, Ireland	Contract manufacturer, Manufacturer	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
Caltag Medsystems Ltd	Buckingham Buckinghamshire, United Kingdom	Manufacturer	0	0	api.fda.gov
Cambridge Diagnostic Products, Inc.	Fort Lauderdale, FL, United States	Manufacturer	0	0	api.fda.gov
Celemics, Inc.	Seoul, South Korea	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
Chaptec America	Montreal Quebec, Canada	Manufacturer	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
Copan Italia	BRESCIA Lombardy, Italy	Manufacturer	1	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
Cytocell Limited	CAMBRIDGE Cambridgeshire, United Kingdom	Complaint file establishment, Manufacturer, Repackager or relabeler	1	0	api.fda.gov
Cytodelics AB	Sodertalje Stockholm, Sweden	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
Diapath S.P.A.	Martinengo Bergamo, Italy	Manufacturer	0	0	api.fda.gov
Diesse Diagnostica Senese S.P.A	MONTERIGGIONI Siena, Italy	Manufacturer	0	0	api.fda.gov
Dirui Industrial Co., Ltd.	CHANGCHUN Jilin, China	Manufacturer	0	0	api.fda.gov
Dna Genotek, Inc.	Ottawa Ontario, Canada	Manufacturer	1	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
Diagnostica Stago - Taverny	Taverny Val-d'Oise, France	Exporter to the US, Manufacturer	0	0	api.fda.gov
Diatron MI Plc	Budapest, Hungary	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
Euroimmun Medizinische Labordiagnostika AG	Luebeck Schleswig-Holstein, Germany	Manufacturer	0	0	api.fda.gov
EUROIMMUN Medizinische Labordiagnostika AG	Dassow Mecklenburg-Western Pomerania, Germany	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
Fertipro N.V.	BEERNEM West-Vlaanderen, Belgium	Manufacturer	0	0	api.fda.gov
Fuzhou Maixin Biotech Co., Ltd.	Fuzhou City Fujian, China	Manufacturer	0	0	api.fda.gov
Fisher Diagnostics	Middletown, VA, United States	Contract manufacturer, Manufacturer	0	0	api.fda.gov
GD Group Co., Ltd.	Eumseong Chungbuk, South Korea	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Genial Helix Ltd	Chester Flintshire, United Kingdom	Manufacturer	0	0	api.fda.gov
Gold Standard Diagnostics, LLC	Davis, CA, United States	Repackager or relabeler, Specification developer	0	0	api.fda.gov
Guangdong Fapon Biotech Co., Ltd.	Dongguan Guangdong, China	Manufacturer	0	0	api.fda.gov
GeneOhm Sciences Canada, ULC.	Quebec, Canada	Manufacturer	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
Hangzhou Healthsky Biotechnology Co., Ltd.	Hangzhou City Zhejiang, China	Manufacturer	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
Himedia Laboratories Private Limited	NASHIK Maharashtra, India	Manufacturer	0	0	api.fda.gov
Horiba Abx SAS	MONTPELLIER Herault, France	Contract manufacturer, Manufacturer, Specification developer	0	0	api.fda.gov
Huachenyang(shenzhen)technology Co., Ltd	Shenzhen Guangdong, China	Manufacturer	0	0	api.fda.gov
Hyphen Biomed Sasu	NEUVILLE SUR OISE Val-d'Oise, France	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
Henan Celnovte Biotechnology Co., Ltd.	zhengzhou Henan, China	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
Ibl International GMBH	Hamburg, Germany	Manufacturer	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
Jeol Ltd.	Musashimurayama Tokyo, Japan	Manufacturer	0	0	api.fda.gov
Jiaoyue Pharmaceutical (huizhou) Co.ltd	Huizhou Guangdong, China	Exporter to the US, Manufacturer	0	0	api.fda.gov
Jinan Babio Biotechnology Co.,ltd.	Jinan City Shandong, China	Exporter to the US, Manufacturer	0	0	api.fda.gov
Jiangsu Medomics Medical Technology Co., Ltd.	Nanjing Jiangsu, China	Manufacturer	0	0	api.fda.gov
Kementec Solutions AS	Taastrup Hovedstaden, Denmark	Manufacturer	0	0	api.fda.gov
Labone, Inc.	Lenexa, KS, United States	Manufacturer	0	0	api.fda.gov
Lacar MDX Technologies	Liege, Belgium	Complaint file establishment, Manufacturer	0	0	api.fda.gov
Leica Biosystems Newcastle Ltd	Newcastle Upon Tyne, United Kingdom	Manufacturer	0	0	api.fda.gov
LGM International Inc.	Melbourne, FL, United States	Manufacturer	0	0	api.fda.gov
Lichtenheldt GMBH	Wahlstedt Schleswig-Holstein, Germany	Contract 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
Luminex Molecular Diagnostics, Inc.	TORONTO Ontario, Canada	Manufacturer	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
Lonza Verviers SRL.	Verviers Liege, Belgium	Contract manufacturer	0	0	api.fda.gov
Lords Mark Industries Ltd.	Daman and Diu Dadra and Nagar Haveli, India	Manufacturer	0	0	api.fda.gov
M Dialysis AB	Stockholm, Sweden	Manufacturer	0	0	api.fda.gov
Medical Chemical Corporation	Torrance, CA, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Medico Technology Co., Ltd	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Melford Laboratories Limited	Ipswich Suffolk, United Kingdom	Contract manufacturer	0	0	api.fda.gov
Merck Kgaa	DARMSTADT Hesse, Germany	Manufacturer	0	0	api.fda.gov
Microbiologics, Inc.	Saint Cloud, MN, United States	Manufacturer	0	0	api.fda.gov
Milestone S.P.A.	Sorisole Bergamo, Italy	Manufacturer	0	0	api.fda.gov
ML LifeSciences	Irvine, CA, United States	Contract manufacturer, Contract sterilizer, Manufacturer	0	0	api.fda.gov
Nanoentek Inc	Hwaseong Gyeonggi, South Korea	Manufacturer	0	0	api.fda.gov
Nanoentek Inc	Seoul, South Korea	Specification developer	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
Ortho-Clinical Diagnostics	Pencoed Bridgend, United Kingdom	Manufacturer	0	0	api.fda.gov
Pathnsitu Biotechnologies Pvt Ltd	HYDERABAD Telangana, India	Manufacturer	0	0	api.fda.gov
Phoenix Diagnostics, Inc.	Natick, MA, United States	Manufacturer	0	0	api.fda.gov
Preomics GMBH	Planegg/Martinsried Bavaria, Germany	Manufacturer	0	0	api.fda.gov
Phase Scientific (Shenzhen) Company Limited	Shenzhen Guangdong, China	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
Qiagen, GMBH	HILDEN North Rhine-Westphalia, Germany	Contract manufacturer, Manufacturer, Specification developer	0	0	api.fda.gov
Ral Diagnostics	Martillac Gironde, France	Manufacturer	0	0	api.fda.gov
Reagent	Runcorn Cheshire West and Chester, United Kingdom	Contract manufacturer	0	0	api.fda.gov
Remel Europe Ltd	Dartford, Kent, United Kingdom	Manufacturer, Specification developer	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 Diagnostics GMBH	MANNHEIM Baden-Wurttemberg, Germany	Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer	0	0	api.fda.gov
Roche Diagnostics GMBH	PENZBERG Bavaria, Germany	Manufacturer	0	0	api.fda.gov
Roche Diagnostics International Ltd.	ROTKREUZ Zug, Switzerland	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 AG & Co. KG	NUMBRECHT North Rhine-Westphalia, Germany	Manufacturer	0	0	api.fda.gov
Sarstedt, Inc.	Newton, NC, United States	Manufacturer	0	0	api.fda.gov
Savyon Diagnostics Ltd.	ASHDOD Southern, Israel	Manufacturer	0	0	api.fda.gov
Scytek Laboratories, Inc.	Logan, UT, United States	Manufacturer	0	0	api.fda.gov
Shanghai Fly Medical Devices Co., Ltd.	Minhang District Shanghai, China	Manufacturer	0	0	api.fda.gov
Shenzhen Dakewe Bio-Engineering Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0	0	api.fda.gov
Shenzhen Dartmon Biotechnology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0	0	api.fda.gov
Shenzhen Yhlo Biotech Co., Ltd.	Shenzhen Guangdong, China	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
Suzhou Sniper Medical Technologies Co., Ltd	Suzhou Jiangsu, China	Manufacturer	0	0	api.fda.gov
Sysmex Corporation Ono Factory	Ono Hyogo, Japan	Manufacturer	0	0	api.fda.gov
Sysmex Corporation Techno Park	KOBE Hyogo, Japan	Specification developer	0	0	api.fda.gov
Shanghai Gene Era Bio-Science Co., Ltd.	Fengxian Shanghai, China	Manufacturer	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
Sysmex Europe SE	Neumunster Schleswig-Holstein, Germany	Contract manufacturer	0	0	api.fda.gov
Takara Biotechnology (dalian) Co., Ltd.	Dalian Liaoning, China	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Tcoag Ireland Limited	BRAY Wicklow, Ireland	Contract manufacturer, Manufacturer	0	0	api.fda.gov
The Binding Site	Kings Norton Birmingham, United Kingdom	Manufacturer	0	0	api.fda.gov
Tosoh Aia, Inc.	Toyama, Japan	Manufacturer	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
The Binding Site Group Ltd.	Birmingham, United Kingdom	Complaint file establishment, Manufacturer	0	0	api.fda.gov
Thermo Fisher Scientific Baltics UAB	Vilnius Vilniaus Miestas, Lithuania	Contract manufacturer, Manufacturer	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
Vitro S.A.	Sevilla, Spain	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
VitalScientific	SEES Normandie, France	Manufacturer	0	0	api.fda.gov
Wallac OY	TURKU Varsinais-Suomi, Finland	Complaint file establishment, Manufacturer	0	0	api.fda.gov
Wavesense, Inc.	Irvine, CA, United States	Manufacturer	0	0	api.fda.gov
Wuhan Landing Intelligence Medical Co.,Ltd	Wuhan Hubei, China	Manufacturer	0	0	api.fda.gov
Xian Tianlong Science And Technology Co., Ltd.	Xi'an Shaanxi, China	Manufacturer	0	0	api.fda.gov
Yiwu Ez Technology Co., Ltd.	Jinhua Zhejiang, China	Manufacturer	0	0	api.fda.gov
Yuaikasei Co.,ltd.	Amagasaki Hyogo, Japan	Contract manufacturer	0	0	api.fda.gov
Zeus Scientific LLC	Branchburg, NJ, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Zhejiang Gene Science Co., Ltd	shaoxing Zhejiang, China	Manufacturer	0	0	api.fda.gov
Zytovision GMBH	Bremerhaven Bremen, Germany	Manufacturer	0	0	api.fda.gov
altona Diagnostics GmbH	Hamburg, Germany	Manufacturer	0	0	api.fda.gov

Updated April 29, 1987. 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.