Chemistry / immunochemistry instrumentsImmunochemistry instrumentsAutomated immunochemistry analysers

Automated immunochemistry analysers - consumables

EMDN code W0201020185

28 manufacturers, 115 models including 114 on the market, 15 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 28

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
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy)	Italy, United States	LIAISON® BAP OSTASE® Specimen Diluent LIAISON® BRAHMS PCT® II GEN Samples diluent LIAISON® Cleaning Kit LIAISON® Disposable Tips LIAISON® EASY Cleaning Tool 9 others LIAISON® EASY Starter Kit LIAISON® EASY System Liquid LIAISON® EASY Wash Buffer LIAISON® Light Check 12 LIAISON® Starter Kit LIAISON® Wash/System Liquid LIAISON® XL Cleaning Tool LIAISON® XL Disposable Tips LIAISON® XL Starter Kit	A IVDR	Website ivdr_dsu@diasorin.com EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United States	ADVIA Centaur Sample Cups, 1500/Pkg IVDR_67_TTN_DUB-C_A_INST_S Cups Atellica Solution Tube Top Sample Cup 1mL IVDR_67_TTN_DUB-C_A_INST_Tube Top Sample Cup2 refs Dimension EMPTY Flex Reagent Cartridge IVDR_67_GLA_DUB-C_A_INST_EMPTY Dimension Sample Cups IVDR_67_GLA_DUB-C_A_INST_Sam Cups Dimension Sample Transfer Module Aliquot Segment IVDR_67_GLA_DUB-C_A_INST_Sample Transfer Mod Aliquot Segment 9 others Dimension Sample Transfer Module Pipette Tips IVDR_67_GLA_DUB-C_A_INST_Sample Transfer Module Pipette Tips Dimension Vista LOCI Reaction Vessel IVDR_67_GLA_DUB-C_A_INST_LOCI Reaction Vessel Dimension XL/RxL Printer Paper IVDR_67_GLA_DUB-C_A_INST_Printed paper Dimension® Chemistry Wash IVDR_67_GLA_DUB-C_A_REAG_Chem Wash Dimension® Cuvette Cartridge IVDR_67_GLA_DUB-C_A_INST_Cuvette Cartridge Dimension® Reaction Vessels IVDR_67_GLA_DUB-C_A_INST_Reaction Vessels Dimension® Sample Probe Cleaner IVDR_67_GLA_DUB-C_A_REAG_Sample Probe Cleaner Dimension® Small Sample Container (SSC) IVDR_67_GLA_DUB-C_A_INST_SSC EZEE-NEST 13-mm Sample Cups IVDR_67_TTN_DUB-C_A_INST_Ez SCup2 refs	A IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
B·R·A·H·M·S FDA	Germany	B·R·A·H·M·S Dilution Plates KRYPTOR GOLD B·R·A·H·M·S KRYPTOR BUFFER B·R·A·H·M·S KRYPTOR compact DILCUP B·R·A·H·M·S KRYPTOR compact REACT B·R·A·H·M·S KRYPTOR compact SOLUTION 1 7 others B·R·A·H·M·S KRYPTOR compact SOLUTION 2 B·R·A·H·M·S KRYPTOR compact SOLUTION 3 B·R·A·H·M·S KRYPTOR compact SOLUTIONS 3 and 42 refs B·R·A·H·M·S KRYPTOR DISK-ANA B·R·A·H·M·S Reaction Plates KRYPTOR GOLD B·R·A·H·M·S Solution 1 KRYPTOR GOLD B·R·A·H·M·S Solution 2 KRYPTOR GOLD B·R·A·H·M·S Solution 3 KRYPTOR GOLD B·R·A·H·M·S Solutions 3 and 4 KRYPTOR GOLD2 refs	A IVDR	EUDAMED record Report an error
Ortho-Clinical Diagnostics FDA EU representative : Ortho-Clinical Diagnostics France (France)	United Kingdom (ex Northern Ireland)	High Sample Diluent A Reagent Pack VITROS High Sample Diluent A VITROS High Sample Diluent B Reagent Pack VITROS High Sample Diluent B VITROS Signal Reagent VITROS 4 others Universal Wash Reagent VITROS VITROS Chemistry Products Immuno-Wash Fluid VITROS Immunodiagnostic Products Maintenance Pack VITROS Immunodiagnostic Products System Cleaning Solution	A IVDR	Website PRRC@quidelortho.com EUDAMED record Report an error
Immunodiagnostic Systems FDA EU representative : Immunodiagnostic Systems SA (Belgium)	Belgium, United Kingdom (ex Northern Ireland)	IDS Immunocleaner IS-IM1002 refs IDS-iSYS D-Sorb Solution IS-DS2003 refs IDS-iSYS Diluent A IDS-iSYS Diluent B IS-10DB IDS-iSYS Diluent C IS-10DC 3 others IDS-iSYS System Liquid (Syst. l) IS-CS1003 refs IDS-iSYS Trigger Set IS-CT1003 refs IDS-iSYS Wash Solution (Wash S) IS-CW1003 refs	A IVDR	Website EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United Kingdom (ex Northern Ireland)	IMMULITE 2000 Allergen Tube Septa IVDR_27_LLB_DUB-C_A_INST_Allergen Tube Septa IMMULITE 2000 Nesting Cups 1mL for 12-mm and 13-mm sample tubes IVDR_27_LLB_DUB-C_A_INST_Nesting Cups2 refs IMMULITE 2000 Systems Diluent Tube Caps IVDR_27_LLB_DUB-C_A_INST_Diluent Tube Caps IMMULITE® 2000 Systems Allergen Tube Caps IVDR_27_LLB_DUB-C_A_INST_Allergen Tube Caps IMMULITE® 2000 Systems Microsampling Tube Caps IVDR_27_LLB_DUB-C_A_INST_MICROSAMPLING TUBE Caps 1 other IMMULITE® 2000 Systems Reaction Tubes IVDR_27_LLB_DUB-C_A_INST_Reaction Tubes	A IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Bindingsite FDA EU representative : The Binding Site Ireland Limited (Ireland)	United Kingdom (ex Northern Ireland)	EXENT® Diluent 1 IK876 EXENT® Elution Buffer 1 IK877 EXENT® HCCA MALDI Matrix Pack IK820 EXENT® Mass Calibration Standard 1 MSS801.M EXENT® Wash Solution 1 IK822	A IVDR	Website info@bindingsite.com EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland)	Serbia	COPROSS SANITIZING SOLUTION COPROSS System liquid COPROSS WASH A COPROSS WASH B Stool extraction system NU1800S, NU1801S, NU1802S, NU1803S3 refs	A IVDR	Website EUDAMED record Report an error
Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium)	Belgium, Japan	AIA-PACK DETECTOR STANDARDIZATION TEST CUP AIA-PACK DILUENT CONCENTRATE AIA-PACK SAMPLE TREATMENT CUP AIA-PACK WASH CONCENTRATE CL AIA-PACK DETECTOR STANDARDIZATION CUP	A IVDR	Website csc@tosoh.co.jp EUDAMED record Report an error
bioMérieux FDA	France	SpinChip SampleTransfer VIDAS® 3 ASSAY DILUTION CUP VIDAS® 3 SAMPLE TIPS VIDAS® Quality Control	A IVDR	EUDAMED record Report an error
Suzhou Hokapi Biomedical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	HOKAPI™ CLEANING HOKAPI™ CLEANING SOLUTION HOKAPI™ SUBSTRATE SOLUTION 1 HOKAPI™ SUBSTRATE SOLUTION 2	A IVDR	EUDAMED record Report an error
Radiometer FDA	Denmark	AQT90 FLEX Blank cartridge Box of 1 pcs. 942-962 AQT90 FLEX Solution pack Cleaning Solution Box of 6 tubes, for AQT90 FLEX 905-843	A IVDR	Website radiometerra_eu@radiometer.dk EUDAMED record Report an error
Randox FDA	Northern Ireland	DISPLACEMENT FLUID CONCENTRATE (DISP FL (conc.)) SIGNAL REAGENT – EV701 (REAG SGNL – EV701)3 refs WASH BUFFER CONCENTRATE (BUF WASH (conc.))	A IVDR	Website EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Chemiluminescence Analyzer Probe Maintenance Cleanser 70mL×42 refs Chemiluminescence Analyzer Tube Maintenance Cleanser 120mL×4 Cleanser REC-L2 refs	A IVDR	Website support@rayto.com EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	STANDARD™ i Cleanser i-CLE-01 STANDARD™ i pre-Trigger i-PTR-01 STANDARD™ i Trigger i-TRG-01	A IVDR	Website EUDAMED record Report an error
Sysmex FDA EU representative : Sysmex Europe SE (Germany)	Japan	HISCL Cuvette L HISCL DISPOSABLE TIP STROMATOLYSER-3WP2 refs (no longer marketed)	A IVDR	ra_archive@sysmex.co.jp EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany)	Ireland, United States	Alinity8 refs ARCHITECT3 refs	A IVDR	Website EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Wako Chemicals Europe GmbH (Germany)	Japan	μTASWako Chip Cassette 993-61601 μTASWako Wash Solution 991-60801	A IVDR	EUDAMED record Report an error
Autobio FDA EU representative : Obelis s.a. (Belgium)	China	5#Tip	A IVDR	Website EUDAMED record Report an error
Biokit FDA	Spain	BIO-FLASH3 refs	A IVDR	EUDAMED record Report an error
Dynex	Czechia	DBH trays	A IVDR	Website EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Alkaline Cleaning Solution AM023	A IVDR	EUDAMED record Report an error
Guangzhou KOFA Biotechnology EU representative : Medunion S.L. (Spain)	China	Washing Solution Please see UDI-DIs for details3 refs	A IVDR	EUDAMED record Report an error
Inova Diagnostics FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	United States	Aptiva Instrument System Cuvettes	A IVDR	Website EUDAMED record Report an error
Medical FDA EU representative : Obelis s.a. (Belgium)	Japan	HM-JACK Reaction Cell3 refs	A IVDR	Website EUDAMED record Report an error
Orgentec	Germany	Alegria Automation Tips Alegria 300 μL Automation Tips	A IVDR	Website EUDAMED record Report an error
Shenzhen Drawray Biotech EU representative : Lotus NL B.V. (Netherlands)	China	96 pcs/rack, 20 racks/box	A IVDR	Website info@szdrawray.com EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	MAGLUMI System Tubing Cleaning Solution	A IVDR	Website 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) 24

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
Phadia AB Present in Europe in other categories	Sweden	Stop Solution Development Solution ImmunoCAP Allergen w1, Common ragweed Washing Solution ImmunoCAP Allergen f15, White bean ImmunoCAP Allergen f55, Common millet	K212181 (2022)
Hycor Biomedical, Inc. Present in Europe in other categories	United States	NOVEOS Cuvette Wash Pack NOVEOS Wheat, Triticum aestivum NOVEOS Egg White, Gallus gallus NOVEOS Diluent A Kit NOVEOS Gal d 2 Ovalbumin, Egg NOVEOS Common Silver Birch, Betula verrucosa	K261027 (2026)
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 Molecular Systems, Inc.	United States	cobas® 6800 system cobas® 8800 system	registered
Precision Biosensor Inc. Present in Europe in other categories	South Korea	Exdia TRF Plus	registered
Diamond Diagnostics Inc. Present in Europe in other categories	United States	–	registered
Genrui Biotech Inc Present in Europe in other categories	China	–	registered
HITACHI HIGH-TECH CORP. Present in Europe in other categories	Japan	–	registered
Hamilton Bonaduz AG	Switzerland	–	registered
Hangzhou Careomedic Tech Co.,Ltd	China	–	registered
Hitachi Chemical Diagnostics, Inc.	United States	–	K193613 (2021)
Infitek Co., Ltd. Present in Europe in other categories	China	–	registered
Jiangsu Konsung Medical Technology Co., Ltd. Present in Europe in other categories	China	–	registered
Labpeak Co.,Ltd	China	–	registered
Medicatec Inc.	Japan	–	registered
Planet Innovation Products, Inc.	United States	–	registered
QUALITY TECH SERVICES, LLC	United States	–	registered
QuidelOrtho Corporation	United States	–	registered
Roche Diagnostics Operations Inc.	United States	–	registered
SST International Inc.	United States	–	registered
Scitek Global Co.,Ltd	China	–	registered
Tecan U.S., Ltd. Present in Europe in other categories	United States	–	registered
Thermo Fisher Scientific Present in Europe in other categories	United States	–	registered
Zhejiang Orient Gene Biotech Co., Ltd Present in Europe in other categories	China	–	registered

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