IVD generic use consumablesDEVICES FOR SAMPLES ANALYSES (no laboratory generic products)
Devices for samples analyses - various
EMDN code W050390
Manufacturers registered in Europe (EUDAMED) 61
- 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.
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) 142
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 |
|---|---|---|---|
| Yancheng Jingwei Chemicals Co., Ltd | China | TANNER HARETA RANKIN PATHSUPLLY CANCER PATHSUPPLY | registered |
| Fisher Scientific Co., LLC | United States | Fisherbrand | K860919 (1986) |
| TYPENEX MEDICAL LLC Present in Europe in other categories | United States | Microscope Cover Glass Microscope Slides Microscope Sldies | registered |
| Leica Biosystems Richmond, Inc. Present in Europe in other categories | United States | Leica Biosystems X-tra Clipped Corner Adhesive Slides, Green | registered |
| Bio-Rad Present in Europe in other categories | United States | Liquichek Lyphochek | K121143 (2012) |
| Slmp, LLC | – | KT ™ Premium Slides | registered |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | ADVIA Centaur® CEA Atellica IM CEA Dimension Vista® Flex® reagent cartridge CEA ADVIA Centaur® CEA Diluent Atellica IM CEA DIL Syva® Emit® Calibrator/Control Level 5 | registered |
| KOVA INTERNATIONAL, INC. | – | KOVA | registered |
| Microgenics Corporation Present in Europe in other categories | United States | MAS DOA Total Liquid Assayed Drugs of Abuse Control MAS PAR TDM Liquid Assayed Therapeutic Drug Control CEDIA Speciality Control Set MAS Tox Control Liquid Assayed Toxicology Control MGC Select DAU Control Set MGC Clinical DAU Control Set | K103656 (2011) |
| Alpha-TEC Systems, Inc. | United States | Alpha-Tec Systems | registered |
| GRAINGER INTERNATIONAL, INC. | – | N/A (Approved Vendor) | registered |
| LIN-ZHI INTERNATIONAL, INC. | United States | Multi-Analyte DAU Control Set C, Level 1 Control Multi-Analyte DAU Control Set E, Level 1 Control Multi-Analyte DAU Control Set A, Level 1 Control DAT Opiates Multi Control I Set Multi-Analyte DAU Control Set C, Level 2 Control Multi-Analyte DAU Control Set F, Level 2 Control | registered |
| Utak Laboratories, Inc. | United States | BARBITURATES 500 NG/ML Lead Level 2 TRICYCLICS LEVEL 2 V2 High Range AED II Mid Range AED II Lead Level 3 | K831736 (1983) |
| Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories | United States | VITROS | K231517 (2023) |
| MEDTOX DIAGNOSTICS, INC. | United States | MEDTOX® PROFILE®-V MEDTOXScan® | registered |
| Abbott Laboratories Present in Europe in other categories | United States | Alinity ARCHITECT | K873183 (1987) |
| BIOSEAL | United States | Bioseal Inc. | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| IMMUNALYSIS CORP | – | Immunalysis | registered |
| Alltrista Plastics LLC Present in Europe in other categories | United States | Kova Plastics | registered |
| CAROLINA LIQUID CHEMISTRIES CORPORATION | United States | CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT BL-425 CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM REAGENT KIT Product No. DT425 CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT ST325 CAROLINA LIQUID CHEMISTRIES CORP.® UDT SELECT CONTROL CLC18022 CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT AU-425 CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT ST425 | registered |
| DEROYAL INDUSTRIES, INC. Present in Europe in other categories | United States | DeRoyal | registered |
| Dynarex Corporation | United States | LabChoice Microscope Cover Glass, 22 x 22 mm LabChoice Microscope Slides,Frosted Pink,Ground Corners LabChoice Microscope Slides, Frosted Yellow, Ground Corner LabChoice Microscope Slides, 75 mm x 25 mm x 1 mm, Frosted LabChoice Microscope Slides, Double Frosted, Ground Corners LabChoice Microscope Slides,Frosted Blue,Ground Corners | registered |
| MONOBIND, INC. Present in Europe in other categories | United States | CEA-NG AccuLite CLIA Test System - 96 Wells CEA AccuBind ELISA Test System - 96 Wells CEA AccuLite CLIA Test System - 96 Wells CEA AccuLite CLIA Test System - 192 Wells CEA-NG AccuBind ELISA Test System - 96 Wells CEA-NG AccuBind ELISA Test System - 192 Wells | registered |
| Randox Laboratories, Ltd. Present in Europe in other categories | United Kingdom | EDDP CONTROL 2 DRUG CONTROL - LEVEL 2 (TDM CONTROL 2) DOA CONTROL 2 THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems) DRUG CONTROL - LEVEL 3 (TDM CONTROL 3) DRUG CONTROL - LEVEL 1 (TDM CONTROL 1) | K012319 (2001) |
| HORIBA INSTRUMENTS INCORPORATED | United States | Pointe Multi-Analyte E DAU Level 1 Control Pointe Multi-Analyte Set D Urine DAU Level 2 Control Pointe Multi-Analyte Set C Urine DAU Level 2 Control Pointe Multi-Analyte E DAU Level 2 Control Pointe Multi-Analyte Set D Urine DAU Level 1 Control Pointe Multi-Analyte Set C Urine DAU Level 1 Control | registered |
| BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY | – | Amerisource Bergen | registered |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | Control Set DAT III Control Set DAT I Cfas DAT Qualitative Plus Clinical Control Set DAT II Control Set DAT Clinical | K080183 (2008) |
| CAPlugs Present in Europe in other categories | United States | Caplugs/Evergreen | registered |
| Dakewe (Shenzhen) Medical Equipment Co., Ltd. | China | Microscope Cover Glass Microscope Slides Adhesion Microscope Slides | registered |
| Fertility Solutions, Inc. | United States | Fertility Solutions | K041240 (2004) |
| Yancheng Huida Medical Instruments Co., Ltd. Present in Europe in other categories | China | StatLab | registered |
| Asp Global, LLC | United States | ASP MEDICAL | registered |
| Becton, Dickinson & CO Present in Europe in other categories | United States | BD Totalys™ SlidePrep Non-GYN Test Kit BD SurePath™ PreCoat Slides BD PrepStain™ Non-GYN Test Kit | registered |
| INFRARED LABORATORY SYSTEMS LLC | United States | Synermed® | registered |
| MARKETLAB INC. | United States | Marketlab, Inc | registered |
| BIO SB, INC. Present in Europe in other categories | United States | Hydrophilic Plus Slides Tinto Detector CapGap Plus Slides | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| GERMAINE LABORATORIES, INC | United States | DOA NEGATIVE CONTROL DOA POSITIVE CONTROL | registered |
| HEMOSURE INC. | – | FIRST SIGN® | registered |
| Henso Medical (Hangzhou) Co., Ltd. | China | Henso | registered |
| Nirmidas Biotech, Inc. | – | pGOLD Slides | registered |
| QUIDEL CARDIOVASCULAR INC. Present in Europe in other categories | – | Triage | registered |
| STANBIO LABORATORY, L.P. | United States | TDM/B-Hydroxybutyrate Bi-Level Controls TDM/B-Hydroxybutyrate Tri-Level Controls | K813349 (1981) |
| Siemens Healthcare Diagnostics Products GmbH Present in Europe in other categories | Germany | IMMULITE®/IMMULITE® 1000 Systems CEA CEA Sample Diluent IMMULITE® 2000 Systems CEA | registered |
| TECHNO-PATH MANUFACTURING LIMITED Present in Europe in other categories | Ireland | Multichem WBT | K132174 (2013) |
| Biomedical Polymers, Inc. | – | BMP 10 CHAMBER ACRYLIC SLIDE (Decislide) | registered |
| Biomet Orthopedics, LLC Present in Europe in other categories | United States | Comprehensive Reverse | registered |
| Ge Medical Systems Information Technologies Present in Europe in other categories | United States | MAC | registered |
| HAMILTON THORNE, INC. | United States | accu-beads® | registered |
| Instant Technologies, Inc. | – | Alere OratectCheck | registered |
| Kolplast C I | Brazil | CELLPRESERV KOLPLAST | registered |
| MARDX DIAGNOSTICS, INC. | United States | Trinity Biotech | registered |
| MEDICAL CHEMICAL CORPORATION | United States | Bone Marrow Kit | registered |
| Ningbo Chiwell Biotechnology Co., Ltd Present in Europe in other categories | China | Chiwell Biotechnology | registered |
| Ventana Medical Systems, Inc. Present in Europe in other categories | United States | VENTANA HE 600 Glass Coverslips | registered |
| ANJI HONGDE MEDICAL PRODUCTS CO., LTD. | China | – | registered |
| ANJI SPENQ INDUSTRIAL CO., LTD. | China | – | registered |
| ASP Tiger, LLc | United States | – | registered |
| Accuster Technologies Pvt. Ltd. | India | – | registered |
| Apothecaries Sundries Mfg Pvt Ltd | India | – | registered |
| Azer Scientific, Inc. | United States | – | registered |
| BIOGENEX LABORATORIES | United States | – | registered |
| BIOMEDICAL POLYMERS, INC. dba BMP Medical | United States | – | registered |
| Bio Nuclear Diagnostics Inc | Canada | – | registered |
| Bio-Dyne, Inc. | United States | – | registered |
| Bio-Gram Diagnostics GmbH Present in Europe in other categories | Germany | – | registered |
| Bionostics, Inc. | United States | – | K063398 (2006) |
| Biosys Co. , Ltd. | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| COPAN ITALIA SPA Present in Europe in other categories | Italy | – | registered |
| Cancer Diagnostics, Inc. | United States | – | registered |
| Celnovte Biotechnology Co., Ltd | China | – | registered |
| Changchun Merydi Bio-Tech Co., Ltd. | China | – | registered |
| Changchun Wancheng Bio-Electron Co., Ltd. | China | – | registered |
| China Shenyang Med-Land Imp/Exp Corp., Ltd. | United States | – | registered |
| Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti | Türkiye | – | registered |
| Diagnostic Automation /Cortez Diagnostics Inc. | United States | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Elsohly Labs, Inc. | United States | – | K951817 (1995) |
| Epredia Holdings Ltd. | United States | – | registered |
| GANGDONG GROUP CO., LTD. Present in Europe in other categories | South Korea | – | registered |
| GST CORPORATION LIMITED Present in Europe in other categories | India | – | registered |
| Guangzhou Four E's Scientific Co., Ltd. Present in Europe in other categories | China | – | registered |
| Guangzhou Labsim Biotech Co., Ltd Present in Europe in other categories | China | – | registered |
| HAIMEN SHENGBANG LABORATORY EQUIPMENT CO., LTD Present in Europe in other categories | China | – | registered |
| HARDY DIAGNOSTICS | United States | – | registered |
| HUA YI MANUFACTORY | China | – | registered |
| HUZHOU JUNDA INDUSTRY CO., LTD. | China | – | registered |
| Hangzhou Rollmed Co.,Ltd. | China | – | registered |
| Hospital & Homecare Imp. & Exp. Co., Ltd | China | – | registered |
| Huida (Vietnam) Medical Instruments Company Limited | Vietnam | – | registered |
| IGE Medical Devices, LLC | United States | – | registered |
| IMMY, Inc. (Immunomycologics, Inc.) Present in Europe in other categories | United States | – | registered |
| Invenio Imaging, Inc. Present in Europe in other categories | United States | – | registered |
| Jiangsu Huida Medical Instruments Co., Ltd. | China | – | registered |
| Jilin Hongyi Bio-Tech Co., Ltd. | China | – | registered |
| Juntech (Jiaxing) Healthcare Materials Co., Ltd. | China | – | registered |
| KNITTEL GLAESER | Germany | – | registered |
| Kolplast CI Ltda Present in Europe in other categories | Brazil | – | registered |
The 100 most active manufacturers are shown, out of 142.
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