IVD instrumentsChemistry / immunochemistry instrumentsImmunochemistry instruments
Automated immunochemistry analysers
EMDN code W02010201
Manufacturers registered in Europe (EUDAMED) 142
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Increcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Illumaxbio EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | Website EUDAMED record Report an error | |
| Euroimmun FDA | Germany | A IVDR | Website info@euroimmun.de EUDAMED record Report an error | |
| Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | Website support@rayto.com EUDAMED record Report an error | |
| DAS | Italy |
1 other
|
A IVDR | Website quality@dasitaly.com EUDAMED record Report an error |
| Lifotronic FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other | China |
|
A IVDR | Website EUDAMED record Report an error |
| Shenzhen Yhlo Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
1 other |
A IVDR | Website info@szyhlo.com EUDAMED record Report an error |
| Vivachek FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other | China |
1 other |
A IVDR | info@vivachek.com EUDAMED record Report an error |
| Aichek FDA EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | ra.rep@aichek.com EUDAMED record Report an error | |
| Aikang MedTech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Autobio FDA EU representative : Obelis s.a. (Belgium) | China |
|
A IVDR | Website EUDAMED record Report an error |
| Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland) | United States | A IVDR | Website EUDAMED record Report an error | |
| bioMérieux FDA | France | A IVDR, 98/79 | EUDAMED record Report an error | |
| Genrui Biotech FDA EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | Website service@genrui-bio.com EUDAMED record Report an error | |
| Gold Standard Diagnostics FDA EU representative : Emergo Europe B.V. (Netherlands) | United States | A IVDR | Website EUDAMED record Report an error | |
| Hitachi High-Tech FDA EU representative : Roche Diagnostics GmbH (Germany) | Japan | A IVDR | ra-contact.aj@hitachi-hightech.com EUDAMED record Report an error | |
| Inova Diagnostics FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | United States | A IVDR | Website EUDAMED record Report an error | |
| Maccura EU representative : Humiss International B.V. (Netherlands) | China | A IVDR | Website EUDAMED record Report an error | |
| Medconn FDA EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other | China | A IVDR | EUDAMED record Report an error | |
| Nanjing Norman Biological Technology EU representative : Sungo Cert GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
A IVDR | Website EUDAMED record Report an error |
| Sophonix EU representative : CMC Medical Devices & Drugs SL (Spain) | China |
|
A IVDR | EUDAMED record Report an error |
| Wesailbio EU representative : Lotus NL B.V. (Netherlands) and 1 other | China | A IVDR | EUDAMED record Report an error | |
| Addcare FDA EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) | China | A IVDR | Website sales@addcare.cn EUDAMED record Report an error | |
| DiaSorin FDA | Italy | A IVDR | Website EUDAMED record Report an error | |
| Linear FDA | Spain | A IVDR | Website info@linear.es EUDAMED record Report an error | |
| Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | Website EUDAMED record Report an error | |
| Orgentec | Germany | A IVDR | Website EUDAMED record Report an error | |
| Vazyme EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other | China | A IVDR | EUDAMED record Report an error | |
| Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) | United States | A IVDR | info@acrobiotech.com EUDAMED record Report an error | |
| Celnovte EU representative : Umedwings Netherlands B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| D-tek | Belgium | A IVDR | Website EUDAMED record Report an error | |
| Dirui FDA EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Dynex Technologies FDA EU representative : Acorn Regulatory Consultancy Services Ltd (Ireland) | United States |
|
A IVDR | Website EUDAMED record Report an error |
| Genobio Pharmaceutical FDA EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | Website marketing@era-bio.com EUDAMED record Report an error | |
| Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Immunodiagnostic Systems FDA EU representative : Immunodiagnostic Systems SA (Belgium) | United Kingdom (ex Northern Ireland) | A IVDR | Website EUDAMED record Report an error | |
| Kangrun EU representative : Sungo Cert GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Monobind FDA EU representative : AR Experts B.V. (Netherlands) | United States | A IVDR | Website info@monobind.com EUDAMED record Report an error | |
| SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | Website EUDAMED record Report an error | |
| Sichuan Orienter Biotechnology EU representative : Lotus NL B.V. (Netherlands) and 1 other | China | A IVDR | Website info@orienterglobal.com EUDAMED record Report an error | |
| Wallac | Finland | A IVDR | Website regulatoryaffairs.turku@revvity.com EUDAMED record Report an error | |
| Zybio FDA EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | PMS@zy-ivd.com EUDAMED record Report an error | |
| Abbott FDA EU representative : Abbott GmbH (Germany) | United States | A IVDR | Website EUDAMED record Report an error | |
| Accucise EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | sales@accucise.cn EUDAMED record Report an error | |
| Adaltis | Italy |
|
– 98/79 | Website info@adaltis.net EUDAMED record Report an error |
| Bindingsite FDA EU representative : The Binding Site Ireland Limited (Ireland) | United Kingdom (ex Northern Ireland) | A IVDR | Website info@bindingsite.com EUDAMED record Report an error | |
| Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| BioFynder EU representative : SUNGO Europe B.V. (Netherlands) | United Kingdom (ex Northern Ireland) | A IVDR | EUDAMED record Report an error | |
| B·R·A·H·M·S FDA | Germany | A IVDR | EUDAMED record Report an error | |
| Diapro | Italy | A IVDR | Website info@diapro.it EUDAMED record Report an error | |
| Erba | Czechia | A IVDR | Website EUDAMED record Report an error | |
| Hipro FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Human | Germany | A IVDR | Website EUDAMED record Report an error | |
| MacroArray Diagnostics | Austria | A IVDR | Website office@madx.com EUDAMED record Report an error | |
| Medcaptain FDA EU representative : R Sight B.V. (Netherlands) | China | A IVDR | Website info@medcaptain.com EUDAMED record Report an error | |
| Ortho-Clinical Diagnostics Rochester EU representative : Ortho-Clinical Diagnostics France (France) | United States | A IVDR | Website PRRC@quidelortho.com EUDAMED record Report an error | |
| Shenzhen Drawray Biotech EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | Website info@szdrawray.com EUDAMED record Report an error | |
| Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) | United States | A IVDR | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| SSI Diagnostica FDA | Denmark | A IVDR, 98/79 | Website info@ssidiagnostica.com EUDAMED record Report an error | |
| Stratec FDA | Germany | A IVDR | Website info@stratec.com EUDAMED record Report an error | |
| Sugentech FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | ra@sugentech.com EUDAMED record Report an error | |
| Suzhou Hokapi Biomedical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Sysmex FDA EU representative : Sysmex Europe SE (Germany) | Japan | A IVDR | ra_archive@sysmex.co.jp EUDAMED record Report an error | |
| Wuhan BGI Biomedical Engineering EU representative : MedPath GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Zhongshan Ruifu Medical Equipment Technology EU representative : Medunion S.L. (Spain) | China | A IVDR | ra@refmedical.net EUDAMED record Report an error | |
| Absology EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | EUDAMED record Report an error | |
| Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain) | United States | A IVDR | info@acesolab.com EUDAMED record Report an error | |
| Agnitio Science &Technology EU representative : CMC Medical Devices & Drugs SL (Spain) | Taiwan | A IVDR | Website contact.us@agnitiost.com EUDAMED record Report an error | |
| Anbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China | A IVDR | info@anbio.com EUDAMED record Report an error | |
| Apollo FDA EU representative : Emergo Europe B.V. (Netherlands) | Taiwan | A IVDR | Website info@apollo.bio EUDAMED record Report an error | |
| Aucheer EU representative : MedPath GmbH (Germany) | China | A IVDR | info_office@aucheer.net EUDAMED record Report an error | |
| Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Biobase Diagnostic Technology (Shandong) EU representative : Luxus Lebenswelt GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Blusense Diagnostics Aps | Denmark | A IVDR | Website info@blusense-diagnostics.com EUDAMED record Report an error | |
| Bosonbio FDA EU representative : MedPath GmbH (Germany) | China | A IVDR | Website EUDAMED record Report an error | |
| Cavanbio EU representative : HyperCert Limited B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Cormay | Poland | A IVDR | regulatory_affairs@cormay.com EUDAMED record Report an error | |
| Diagreat EU representative : Medunion S.L. (Spain) | China | A IVDR | Website info@diagreat.com EUDAMED record Report an error | |
| Diesse FDA | Italy | A IVDR | Website EUDAMED record Report an error | |
| Draeger FDA | Germany | – 98/79 | Website EUDAMED@draeger.com EUDAMED record Report an error | |
| Dymind EU representative : Eunitor GmbH (Germany) | China | A IVDR | regulationdept@dymind.com EUDAMED record Report an error | |
| E-LAB Biological Science & Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Eiken FDA EU representative : Advena Limited (Malta) | Japan | A IVDR | regulatoryaffairs@eiken.co.jp EUDAMED record Report an error | |
| Eurospital FDA | Italy |
|
A IVDR | regulatory@eurospital.it EUDAMED record Report an error |
| General Biologicals EU representative : Medical Technology Promedt Consulting GmbH (Germany) | Taiwan | A IVDR | sales.group@gbc.com.tw EUDAMED record Report an error | |
| Guangzhou KOFA Biotechnology EU representative : Medunion S.L. (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Guangzhou LBP Medicine Science & Technology EU representative : Kingsmead Service B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | info@alltests.com.cn EUDAMED record Report an error | |
| Hebei Sanxin Pharmaceutical Technology EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Hunan Drawray Biotech EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | info@szdrawray.com EUDAMED record Report an error | |
| Hycor Biomedical FDA EU representative : Advena Limited (Malta) | United States | A IVDR | Website info@hycorbiomedical.com EUDAMED record Report an error | |
| Immundiagnostik FDA | Germany |
|
A IVDR | Website info@immundiagnostik.com EUDAMED record Report an error |
| ImmunoDiagnostic Systems France FDA | France | A IVDR | Website EUDAMED record Report an error | |
| Jiezibio EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Keylights EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Labsystems Diagnostics FDA | Finland | A IVDR | Website EUDAMED record Report an error | |
| Lituo EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Lordsmark EU representative : Obelis s.a. (Belgium) | India | A IVDR | Website EUDAMED record Report an error | |
| Medical FDA EU representative : Obelis s.a. (Belgium) | Japan | A IVDR | Website EUDAMED record Report an error | |
| Meril Diagnostics FDA EU representative : Obelis s.a. (Belgium) | India | A IVDR | Website ram.kanoje@merillife.com EUDAMED record Report an error | |
| NanoEntek FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea |
|
A IVDR | Website eudamed@nanoentek.com EUDAMED record Report an error |
| Neomedica EU representative : Wellkang Ltd (Northern Ireland) | Serbia | A IVDR | Website EUDAMED record Report an error | |
| Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain) | China | A IVDR | Website info@kylinew.com EUDAMED record Report an error | |
| Next Level | Italy |
|
A IVDR | EUDAMED record Report an error |
| Paitzar EU representative : Metridium OÜ (Estonia) | Iran | A IVDR | Website info@paitzar.am EUDAMED record Report an error | |
| PCL EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | Website EUDAMED record Report an error | |
| Phadia FDA | Sweden |
|
A IVDR | Website RegulatoryAffairs.Uppsala.IDD@thermofisher.com EUDAMED record Report an error |
| Protia EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | EUDAMED record Report an error | |
| Pushkang EU representative : Sungo Cert GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Quidel Cardiovascular FDA EU representative : MDSS GmbH (Germany) | United States |
|
– 98/79 | Website PRRC@quidelortho.com EUDAMED record Report an error |
| Radiometer FDA | Denmark | A IVDR | Website radiometerra_eu@radiometer.dk EUDAMED record Report an error | |
| Randox FDA | Northern Ireland | A IVDR | Website EUDAMED record Report an error | |
| Rapid Labs EU representative : Advena Limited (Malta) | United Kingdom (ex Northern Ireland) | A IVDR | Website info@rapidlabs.co.uk EUDAMED record Report an error | |
| Realmindbio EU representative : Sungo Cert GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Renderbio EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Sansure FDA EU representative : Obelis s.a. (Belgium) | China |
|
A IVDR | Website info@sansure.com.cn EUDAMED record Report an error |
| Seamaty EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Shanghai Kehua Laboratory System FDA EU representative : Obelis s.a. (Belgium) | China | A IVDR | Website EUDAMED record Report an error | |
| Shenzhen AmTech Bioengineering EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Shenzhen Dake Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Shenzhen Tailaored Medical EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | Website sales@szzijian.com EUDAMED record Report an error | |
| Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) | United Kingdom (ex Northern Ireland) | A IVDR | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| Singuway EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | sales@singuway.com EUDAMED record Report an error | |
| Sinseng EU representative : Sungo Cert GmbH (Germany) | China | A IVDR | service@sinseng.com.cn EUDAMED record Report an error | |
| Skyla EU representative : Medical Technology Promedt Consulting GmbH (Germany) | Taiwan | A IVDR | Website EUDAMED record Report an error | |
| Sunlant EU representative : MedPath GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Suzhou Astrabio Technology EU representative : MedPath GmbH (Germany) | China | A IVDR | marketing@astra-biotech.com EUDAMED record Report an error | |
| Suzhou Sym-Bio Lifescience EU representative : Emergo Europe B.V. (Netherlands) | China |
|
A IVDR | quality.taicang@revvity.com EUDAMED record Report an error |
| Taizhou Zecen Biotech EU representative : MedPath GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| tascom EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | EUDAMED record Report an error | |
| Technogenetics FDA | Italy | A IVDR | Website QA@TECHNOGENETICS.IT EUDAMED record Report an error | |
| Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium) | Japan | A IVDR | csc@tosoh.co.jp EUDAMED record Report an error | |
| Urit FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | Website service@uritest.com EUDAMED record Report an error | |
| Virtue Diagnostics (Suzhou) EU representative : Kingsmead Service B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Wizbiotech EU representative : QbD RepS BV (Belgium) | China | A IVDR | EUDAMED record Report an error | |
| Wondfo FDA EU representative : QbD RepS BV (Belgium) | China | A IVDR | Website sales@wondfo.com.cn EUDAMED record Report an error | |
| Zhejiang Gewuzhizhi Biotechnology EU representative : Llins Service & Consulting GmbH (Germany) | China | A IVDR | Website EUDAMED record Report an error | |
| Zhongshan Chuangyi Biochemical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Chemclin EU representative : MedNet EC-REP GmbH (Germany) No model still on the market | China |
|
A IVDR | Website EUDAMED record Report an error |
| QuantaMatrix EU representative : KTR Europe GmbH (Germany) No model still on the market | South Korea |
|
– 98/79 | EUDAMED record Report an error |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 58
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Minaris Medical America, Inc. | – | CLA® Allergen-Specific IgE Assay - Southeastern Inhalant Panel CLA® Positive Control Serum CLA-1™ Luminometer AP 720S™ Semi-Automated Processor OPTIGEN® AP 3600™ Automated Instrument OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36 Panel | registered |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | Tinaquant IgG Gen2 IGG Immunoglobulin G Turbidimetric) Tina-quant IgG Gen.2 | K050113 (2005) |
| Quidel Corp. | United States | Sofia | registered |
| AGILENT TECHNOLOGIES SINGAPORE PTE LTD Present in Europe in other categories | – | Poly Rb a Hu Alpha-1-Antitrypsin Poly Rb A-Hu IgG Poly Rb A-Hu IgA, IgG, IgM | registered |
| Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. Present in Europe in other categories | China | Macro & Micro-Test Fluorescence Immunoassay Analyzer Immunofluorescence Reader | registered |
| Response Biomedical Corp. Present in Europe in other categories | Canada | RAMP® 200 CM Control Module RAMP® 1 Clinical Reader System RAMP® 200 TM Test Module | registered |
| SANWA BIOTECH LIMITED | – | ALiA FIA Analyser Ariel Fluorescent Immunoassay System Thetis Fluorescent Immunoassay System | registered |
| Guangzhou Labsim Biotech Co., Ltd Present in Europe in other categories | China | – | registered |
| Immuno Concepts, Inc. Present in Europe in other categories | United States | Image Navigator® | registered |
| MBD CO., Ltd. Present in Europe in other categories | South Korea | ASFA® SCANNER ASFA SCANNER | registered |
| Roche Molecular Systems, Inc. | United States | cobas® 6800 system cobas® 8800 system | registered |
| Shenzhen Superbio Technology Co., Ltd. Present in Europe in other categories | – | Superbio Immunofluorescence Analyzer Bioeasy Immunofluorescence Analyzer | registered |
| Zeus Scientific, Inc. Present in Europe in other categories | United States | Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) | K924197 (1992) |
| Abionic SA Present in Europe in other categories | Switzerland | abioSCOPE | registered |
| Aesku.Diagnostics GmbH & Co. KG Present in Europe in other categories | Germany | HELIOS® Automated IFA System | registered |
| Aesku.Systems GmbH & Co. KG Present in Europe in other categories | – | HELIOS | registered |
| CAROLINA LIQUID CHEMISTRIES CORPORATION | United States | Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYAN | registered |
| HEALGEN LIFE SCIENCE, LLC Present in Europe in other categories | United States | Healgen | registered |
| HORIBA ABX SAS Present in Europe in other categories | France | Yumizen C1200 Immunoglobulin G | registered |
| Kamiya Biomedical Co. Present in Europe in other categories | United States | K-ASSAY® IgG Reagent | K993281 (1999) |
| Kent Laboratories, Inc. | United States | Antiserum to Human IgG (gamma chain specific) | K790702 (1979) |
| Lacar MDX Technologies Present in Europe in other categories | Belgium | SEEKER® | registered |
| Precision Biosensor Inc. Present in Europe in other categories | South Korea | Exdia TRF Plus | registered |
| Tecan U.S., Ltd. Present in Europe in other categories | United States | INFINITE 200 PRO | registered |
| Agilent Technologies, Inc. Present in Europe in other categories | United States | – | registered |
| BIT Analytical Solutions GmbH | Germany | – | registered |
| BioSquare Inc. | South Korea | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Emsere, Inc | Netherlands | – | registered |
| GST CORPORATION LIMITED Present in Europe in other categories | India | – | registered |
| Hamilton Bonaduz AG | Switzerland | – | registered |
| Hangzhou Careomedic Tech Co.,Ltd | China | – | registered |
| Hitachi Chemical Diagnostics, Inc. | United States | – | K193613 (2021) |
| Hologic, Inc. Present in Europe in other categories | United States | – | registered |
| IUL SA | Spain | – | registered |
| Infitek Co., Ltd. Present in Europe in other categories | China | – | registered |
| Instrumentation Laboratory CO Present in Europe in other categories | United States | – | registered |
| Jabil Inc. | United States | – | registered |
| Jiangsu Konsung Medical Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| LRE MEDICAL GMBH | Germany | – | registered |
| Labpeak Co.,Ltd | China | – | registered |
| Medicatec Inc. | Japan | – | registered |
| NANO-DITECH CORPORATION | United States | – | registered |
| Nittobo Medical Co., Ltd. | Japan | – | registered |
| Planet Innovation Products, Inc. | United States | – | registered |
| QUALITY TECH SERVICES, LLC | United States | – | registered |
| QuidelOrtho Corporation | United States | – | registered |
| Revvity, Inc. Present in Europe in other categories | United States | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| SST International Inc. | United States | – | registered |
| STS Corporation | United States | – | registered |
| Scantibodies Laboratory Inc. | United States | – | registered |
| Scitek Global Co.,Ltd | China | – | registered |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | registered |
| Tosoh Bioscience, Inc. | United States | – | registered |
| Via systems Manufacturas | Mexico | – | registered |
| W.H.P.M. Bioresearch & Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| Zhejiang Orient Gene Biotech Co., Ltd Present in Europe in other categories | China | – | registered |
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