ReagentsHaematology / haemostasis / immunohaematology / histology / cytologyHaematology reagents
Reagents for (automated) haematology analyzer
EMDN code W01030101
Manufacturers registered in Europe (EUDAMED) 78
- 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) 65
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 |
|---|---|---|---|
| Beckman Coulter, Inc. Present in Europe in other categories | United States | AQUIOS DxH DxH 500 Series Lyse COULTER DxH Cell Lyse Q-PREP/IMMUNOPREP REAGENT SYSTEM COULTER DxH Diff Pack | registered |
| DREW SCIENTIFIC, INC. | United Kingdom | Drew Scientific JAS Diagnostics | registered |
| Advanced Instruments, Inc. Present in Europe in other categories | United States | Advanced Instruments GloCyte® Count Template Cartridge Advanced Instruments RBC Reagent Filtration Kit Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume Advanced Instruments GloCyte® Instrument Assembly Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays Advanced Instruments GloCyte® Automated Cell Counter System | K152776 (2016) |
| Phoenix Diagnostics, Inc. | United States | PHOENIX DIAGNOSTICS, INC. Phoenix Diagnostics | registered |
| CAROLINA LIQUID CHEMISTRIES CORPORATION | United States | CLC FAST DETERGENT 1 ALKALINE WASHING SOLUTION 100263 CAROLINA LIQUID CHEMISTRIES CORP.® WASH CONCENTRATE ST160 CAROLINA LIQUID CHEMISTRIES CORP.® WASH CONCENTRATE KIT 88805 CAROLINA LIQUID CHEMISTRIES CORP.® WASH SOLUTION AU-160 CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE WASH SOLUTION DT160 CAROLINA LIQUID CHEMISTRIES CORP.® WASH SOLUTION AU-2000 | registered |
| Germiphene Corporation | Canada | Surgical Milk ET Foam | registered |
| IMMUNOTECH Present in Europe in other categories | United States | Beckman coulter Beckmancoulter | registered |
| MICRO-SCIENTIFIC, LLC | – | Micro-Scientific Enzyclean IV Micro-Scientific Enzyclean II Micro-Scientific Enzyclean Micro-Scientific MicroKleen LS Micro-Scientific MicroKleen HS Micro-Scientific Enzyclean II LS | registered |
| Siemens Healthcare Diagnostics Products GmbH Present in Europe in other categories | Germany | IMMULITE® 2000 Systems MD2 Multi-Diluent 2 Sample Diluent IMMULITE® 1000 System ID1 IgG/IgM Sample Diluent IMMULITE® 2000 Systems ID1 IgG/IgM Sample Diluent IMMULITE® 2000 Systems MD1 Multi-Diluent 1 Neodisher® GK | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| DIAGNOSTIC GRIFOLS SA Present in Europe in other categories | Spain | Grifols Wash Solution B Grifols Wash Solution A DG Clean | registered |
| MONOBIND, INC. Present in Europe in other categories | United States | 0 Calibrator Matrix for Steroid (All) and Thyroid (T3, T4) Sample Diluent hCG-Free for High-Value Pregnancy Samples 0 Calibrator Matrix for FSH, Ferritin, Folate & Vit B12 0 Calibrator Matrix For Multi-Ligands Serum Diluent Concentrate 10X (20.1ml) for High-Value x-H Pylori, x-Tg and x-TPO | registered |
| FUJIREBIO INC. Present in Europe in other categories | – | Lumipulse G Specimen Diluent 1 Lumipulse G Specimen Diluent 2 Lumipulse G Specimen Diluent 6 Lumipulse G Specimen Diluent 3 | registered |
| Becton, Dickinson & CO Present in Europe in other categories | United States | FACS FACSCount Reticcount | registered |
| KOROS U.S.A., INC. | United States | Needle Holder | registered |
| TOSOH CORPORATION Present in Europe in other categories | United States | CL AIA-PACK Progesterone SAMPLE DILUTING REAGENT CL AIA-PACK SAMPLE DILUTING REAGENT A CL AIA-PACK SAMPLE DILUTING REAGENT D | registered |
| UROCARE PRODUCTS, INC. | – | Urocare® Urinary & Ostomy Appliance Cleaning Brush 8" (20cm) Urolux® Urinary & Ostomy Appliance Cleanser/Deodorant, Standard 16 oz. (473 mL.) Urolux® Urinary and Ostomy Appliance Cleanser & Deodorant, Trial 4 oz. (118 mL.) | registered |
| AGILENT TECHNOLOGIES SINGAPORE PTE LTD Present in Europe in other categories | – | IntraStain EasyLyse Erythrocyte-Lysing Reagent | registered |
| Bühlmann Laboratories AG | Switzerland | CAST® Lysing Reagent Basophil CAST® Stimulation Buffer Basophil | registered |
| HAMILTON THORNE, INC. | United States | IVOS CEROS | registered |
| Hemocue AB Present in Europe in other categories | United States | HemoCue® WBC Microcuvettes HemoCue® WBC Analyzer | K071652 (2007) |
| Incell Corporation, LLC | United States | ZAPR™ | registered |
| American National Red Cross | – | Red Cell Storage Solution | registered |
| Bio-Rad Medical Diagnostics GmbH Present in Europe in other categories | – | Wash Solution A Concentrate | registered |
| Fisher Diagnostics | United States | Thermo Scientific Nerl® | registered |
| IMMUCOR, INC. Present in Europe in other categories | United States | Red Blood Cell (RBC) Storage Solution | registered |
| Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories | United States | VITROS | registered |
| Randox Laboratories, Ltd. Present in Europe in other categories | United Kingdom | RANSOD DILUENT (RANSOD DIL) | registered |
| Stemcell Technologies Canada Inc Present in Europe in other categories | Canada | EasySep™ Red Blood Cell Lysis Buffer, 10X Concentrate | registered |
| Tosoh Bioscience, Inc. | United States | Hemolysis and Wash Solution | registered |
| AMERICAN NATIONAL RED CROSS HEADQUARTERS | United States | – | registered |
| Agilent Technologies, Inc. Present in Europe in other categories | United States | – | registered |
| Antibodies, Inc. | United States | – | registered |
| Azer Scientific, Inc. | United States | – | registered |
| BIT Group France | France | – | registered |
| Bio-Rad Laboratories (Bio-Rad Services France) Present in Europe in other categories | France | – | registered |
| COPAN ITALIA SPA Present in Europe in other categories | Italy | – | registered |
| Cliniqa Corporation | United States | – | registered |
| DiaMed GmbH (Bio-Rad Laboratories) Present in Europe in other categories | Switzerland | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Diatron MI Plc | Hungary | – | registered |
| Diazyme Laboratories Present in Europe in other categories | United States | – | registered |
| E K INDUSTRIES, INC. | United States | – | registered |
| ELHoda trade and supplies | Egypt | – | registered |
| HEMO BIOSCIENCE INC | United States | – | registered |
| High Technology, Inc. Present in Europe in other categories | United States | – | registered |
| Infitek Co., Ltd. Present in Europe in other categories | China | – | registered |
| JAS Diagnostics/Drew Scientific | United States | – | registered |
| Labpeak Co.,Ltd | China | – | registered |
| MEDICAL CHEMICAL CORPORATION | United States | – | registered |
| MicroCare, LLC | United States | – | registered |
| PREDO SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI | Türkiye | – | registered |
| QuidelOrtho Corporation | United States | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Scitek Global Co.,Ltd | China | – | registered |
| Streck Laboratories, Inc. Present in Europe in other categories | United States | – | K802636 (1980) |
| TECHNOGENETICS SPA Present in Europe in other categories | Italy | – | registered |
| THE BINDING SITE GROUP LIMITED Present in Europe in other categories | United States | – | registered |
| Technoclone Herstellung v. Diagnostika u. Arzneimitteln GmbH | Austria | – | registered |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | registered |
| UAB KITRON | Lithuania | – | registered |
| WEIMAN PRODUCTS, LLC | United States | – | registered |
| WaveSense, Inc. dba nRichDX | United States | – | registered |
| Young Innovations, Inc. | United States | – | registered |
| Zhejiang GENE SCIENCE Co., Ltd | China | – | registered |
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