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Data / Medical devices / Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE): 151 FDA-registered makers in 22 countries

151 establishments in 22 countries are registered with the FDA to make Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (product code JJE, Class 1, 21 CFR 862.2160). 28 of them have a 510(k) clearance or PMA approval on file and 21 have a recall event. The FDA has issued 208 510(k) clearances under this code, the latest on February 12, 2019, and lists 334 recall events (0 Class I). FDA data exported November 3, 2026.

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Get every maker of this deviceMakers in the United StatesWatch this device
Product code
JJE
Device class
1
Regulation
862.2160
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States55
Japan21
China18
Germany10
United Kingdom7
Italy6
France5
Ireland5
Switzerland4
Hungary2
Finland2
Canada2
India2
Mexico2
Belgium2
Taiwan2
Egypt1
Singapore1
Greece1
Sweden1
Monaco1
Netherlands1

Makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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
Diamond Diagnostics Inc.Budapest, HungaryContract manufacturer, Exporter to the US18March 22, 2013000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesComplaint file establishment, Manufacturer, Specification developer7March 22, 20130380api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler3April 8, 1997000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer2January 17, 19950500api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer, Repackager or relabeler, Specification developer2March 14, 2005000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer2April 8, 19970180api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer, Repackager or relabeler2May 8, 2008000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1May 17, 2012000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer, Specification developer1March 10, 19970620api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesManufacturer1January 28, 20030250api.fda.gov
Biomerieux Italia-Industrial Div.PONTE-A EMA, FLORENCE Firenze, ItalyManufacturer1February 12, 1993000api.fda.gov
Biomerieux SALA BALME LES GROTTES Isere, FranceSpecification developer1February 12, 1993000api.fda.gov
BIOTECNICA INSTRUMENTS, SrlROME Roma, ItalyManufacturer1April 20, 1995000api.fda.gov
Beckman Coulter K. K.Sunto-Gun Shizuoka, JapanSpecification developer1July 5, 1996000api.fda.gov
Biolis Medical Corp.Hino Tokyo, JapanManufacturer1February 15, 2005000api.fda.gov
Carolina Liquid ChemistriesBrea, CA, United StatesComplaint file establishment, Specification developer1May 16, 2014000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer, Manufacturer for export1September 21, 1993000api.fda.gov
Horiba Abx SASMONTPELLIER Herault, FranceManufacturer, Specification developer1February 12, 2019000api.fda.gov
Horiba Ltd.Kyoto, JapanContract manufacturer, Exporter to the US, Specification developer1February 12, 2019000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer1January 17, 1995010api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer, Manufacturer1January 9, 2014000api.fda.gov
Randox Laboratories LimitedANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomManufacturer1January 9, 2014000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler, Specification developer1June 14, 1996000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer1June 14, 1996000api.fda.gov
Sanzay Corporation -Miami Gardens, FL, United StatesRemanufacturer, Repackager or relabeler1May 15, 2014000api.fda.gov
Siemens Healthcare Diagnostics Products LimitedLLANBERIS Wales, United KingdomManufacturer, Specification developer1April 8, 1997000api.fda.gov
Thermo Fisher Scientific OYVANTAA Uusimaa, FinlandContract manufacturer, Manufacturer1June 28, 2011000api.fda.gov
VitalScientificSEES Normandie, FranceManufacturer1April 20, 1995000api.fda.gov
Abbott IrelandSligo, IrelandManufacturer0000api.fda.gov
Abbott Ireland Diagnostics DivisionLongford, IrelandManufacturer0000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesManufacturer, Specification developer0050api.fda.gov
Abbott LaboratoriesAbbott Park, IL, United StatesManufacturer0070api.fda.gov
Abbott Point Of Care Canada LimitedOttawa Ontario, CanadaManufacturer0000api.fda.gov
Abbott Point Of Care Inc.Princeton, NJ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Accuster Technologies Pvt. Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Ari Medical Technology Co., Ltd.Hefei Anhui, ChinaManufacturer0000api.fda.gov
Awareness Technology, Inc.Palm City, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Abbott Automation Solutions GmbHHamburg, GermanyManufacturer0000api.fda.gov
Abbott Laboratories de MexicoCuautitlan Izcalli Mexico, MexicoContract manufacturer0000api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesManufacturer0010api.fda.gov
Beckman Coulter Laboratory Systems (suzhou) Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer, Specification developer0010api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Beijing Hotgen Biotech Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Bio-RadSTEENVOORDE Nord, FranceManufacturer0000api.fda.gov
Bio-RadMARNES-LA-COQUETTE Ile-de-France, FranceSpecification developer0000api.fda.gov
Biobase Biodustry(shandong)co., LtdJinan Shandong, ChinaManufacturer0000api.fda.gov
Beckman Coulter Biomedical GmbHBaierbrunn Bavaria, GermanyContract manufacturer0000api.fda.gov
Beckman Coulter Biomedical GmbHMunchen Bavaria, GermanySpecification developer0020api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandContract manufacturer0000api.fda.gov
Beckman Coulter Mishima K.K.SUNTO-GUN Shizuoka, JapanContract manufacturer0040api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Canon Inc.OTAWARA-SHI Tochigi, JapanContract manufacturer0000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesContract manufacturer0000api.fda.gov
Currier PlasticsAuburn, NY, United StatesContract manufacturer0000api.fda.gov
Carclo Technical Plastics - LatrobeLatrobe, PA, United StatesContract manufacturer0000api.fda.gov
Classic Industries, Inc.Latrobe, PA, United StatesContract manufacturer0000api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesManufacturer0000api.fda.gov
Diesse Diagnostica Senese S.P.AMONTERIGGIONI Siena, ItalyManufacturer0000api.fda.gov
Dirui Industrial Co., Ltd.CHANGCHUN Jilin, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan Bao Kang Dian Zi Ke Ji LimitedDongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
DiaSorin Deutschland GmbHDietzenbach Hesse, GermanyContract manufacturer0000api.fda.gov
DiaSorin Italia S.p.A UK BranchDartford Kent, United KingdomContract manufacturer0000api.fda.gov
DiaSorin Italia S.p.A.SALUGGIA Vercelli, ItalyManufacturer, Specification developer0000api.fda.gov
Diatron MI PlcBudapest, HungaryManufacturer0000api.fda.gov
Diazyme Laboratories, Inc.Poway, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Elhoda Trade And SuppliesBadr industerial city Al Qahirah, EgyptManufacturer0000api.fda.gov
ELITechGroup IncLogan, UT, United StatesContract manufacturer0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Euroimmun Medizinische Labordiagnostika AGLuebeck Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
EUROIMMUN Medizinische Labordiagnostika AGDassow Mecklenburg-Western Pomerania, GermanyManufacturer0000api.fda.gov
Fandf Co., Ltd. Medical Device DepartmentHachioji-shi Tokyo, JapanContract manufacturer0000api.fda.gov
Furuno Electric Co., Ltd.NISHINOMIYA-CITY Hyogo, JapanManufacturer0000api.fda.gov
Flextronics Manufacturing (Singapore) Pte LtdSINGAPORE South East, SingaporeContract manufacturer0000api.fda.gov
Fujirebio Diagnostics, Inc.Seguin, TX, United StatesManufacturer0000api.fda.gov
Fujirebio Europe N.V.GHENT Oost-Vlaanderen, BelgiumExporter to the US, Specification developer0000api.fda.gov
Fujirebio Inc.Sagamihara-shi Kanagawa, JapanManufacturer0000api.fda.gov
Fujirebio Inc. Ube FacilityYamaguchi, JapanManufacturer0000api.fda.gov
Getein Biotech, Inc.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Gold Standard Diagnostics, LLCDavis, CA, United StatesManufacturer0000api.fda.gov
Hamilton Co.Reno, NV, United StatesContract manufacturer0010api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Hitachi High-Tech Corp., Naka DivisionHitachinaka-shi Ibaraki, JapanContract manufacturer0000api.fda.gov
Hycor BiomedicalGarden Grove, CA, United StatesManufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hitachi High-Tech Corp., Omuta CenterOmuta-shi Fukuoka, JapanContract manufacturer0000api.fda.gov
Ids Co, LtdKumamoto-Shi, JapanContract manufacturer0000api.fda.gov
Immunodiagnostic Systems Ltd.Boldon Colliery Durham, United KingdomManufacturer0000api.fda.gov
Inova Diagnostics, Inc.San Diego, CA, United StatesManufacturer0010api.fda.gov
Inpeco S.P.A.Val della Torre Torino, ItalyContract manufacturer0000api.fda.gov
Inpeco SANovazzano Ticino, SwitzerlandExporter to the US, Specification developer0010api.fda.gov
Instrumentation Laboratory Co.Bedford, MA, United StatesManufacturer0000api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer0000api.fda.gov
Ixensor Co LtdTaipei, TaiwanManufacturer0000api.fda.gov
Immunodiagnostic Systems SALiege, BelgiumContract manufacturer, Manufacturer0000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer0000api.fda.gov
Jeol Ltd.Musashimurayama Tokyo, JapanManufacturer0000api.fda.gov
Kikuyo FactoryKumamoto, JapanManufacturer0000api.fda.gov
Labsystems DiagnosticsVantaa Uusimaa, FinlandManufacturer0000api.fda.gov
LMSI, LLC dba Lighthouse Lab ServicesCarrollton, TX, United StatesManufacturer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer0010api.fda.gov
Medicon Hellas SAGERAKAS Attiki, GreeceContract manufacturer, Manufacturer0000api.fda.gov
MGS Germantown A Division Of MGS Group NA IncGermantown, WI, United StatesContract manufacturer0000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer, Manufacturer for export0000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
NPA de México S. de R.L. de C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Ningbo MedicalSystem Biotechnology Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
Nypro Inc. (Chicago)Gurnee, IL, United StatesContract manufacturer0000api.fda.gov
Opti Medical Systems Inc.Roswell, GA, United StatesManufacturer0010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer0020api.fda.gov
Otsuka Electronics Co., Ltd.Koka-city Shiga, JapanContract manufacturer0000api.fda.gov
Ortho-Clinical DiagnosticsPencoed Bridgend, United KingdomManufacturer0000api.fda.gov
Phadia ABUppsala, SwedenManufacturer, Specification developer0000api.fda.gov
PHC CorporationTako-machi Katori-gun Chiba, JapanComplaint file establishment, Specification developer0000api.fda.gov
Precision System Science Company LimitedMatsudo-city Chiba, JapanContract manufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer, Specification developer0000api.fda.gov
Randox TeorantaDungloe Donegal, IrelandForeign private label distributor, Manufacturer0000api.fda.gov
SafasMonaco Monaco-Ville, MonacoManufacturer0000api.fda.gov
Sentinel CH. SPAMilano, ItalyContract manufacturer, Manufacturer0000api.fda.gov
Sequitur Health Corp.Phoenix, AZ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Shanghai Kehua Laboratory System Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shenzhen Increcare Biotech Co., LtdShen Zhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen New Industries Biomedical Engineering Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Yhlo Biotech Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Stratec SeBIRKENFELD, GRAEFENHAUSEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
STRATEC Switzerland AGBeringen Schaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Sysmex CorporationKOBE Hyogo, JapanManufacturer0000api.fda.gov
Sysmex Corporation Techno ParkKOBE Hyogo, JapanSpecification developer0000api.fda.gov
Sekisui Diagnostics P.E.I. Inc.CHARLOTTETOWN Prince Edward Island, CanadaContract manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer0030api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.SWORDS Dublin(County), IrelandManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Products GmbHMARBURG Hesse, GermanyContract manufacturer0000api.fda.gov
Taidoc Technology CorporationNew Taipei City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Tecan Schweiz AGMAENNEDORF ZUERICH Zurich, SwitzerlandManufacturer0000api.fda.gov
Tessy Plastics Corp.Elbridge, NY, United StatesContract manufacturer0000api.fda.gov
TN Michigan, LLCSault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
The Binding Site Group Ltd.Birmingham, United KingdomComplaint file establishment, Manufacturer0020api.fda.gov
Tosoh Hi-Tec, Inc.Yamaguchi, JapanManufacturer0000api.fda.gov
Trinity Biotech (Primus Corporation dba Trinity Biotech)Kansas City, MO, United StatesManufacturer for export0000api.fda.gov
VitalScientific B.V.SPANKEREN Gelderland, NetherlandsManufacturer0010api.fda.gov
Wuxi Biohermes Bio & Medical Technology Co., Ltd.Wuxi Jiangsu, ChinaManufacturer0000api.fda.gov
Westfall Technik ChicagoAntioch, IL, United StatesContract manufacturer0000api.fda.gov
Yamura Electric Industry Co., Ltd.KITAKAMI-SHI Iwate, JapanContract manufacturer0000api.fda.gov
Yantai Addcare Bio-Tech Co., Ltd.Yantai Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zybio Inc.Chongqing, ChinaManufacturer0000api.fda.gov

Updated February 12, 2019. 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.