ReagentsHaematology / haemostasis / immunohaematology / histology / cytology
Haematology reagents
EMDN code W010301
Manufacturers registered in Europe (EUDAMED) 177
- 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.
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Other manufacturers known in the United States (FDA) 165
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 |
|---|---|---|---|
| RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | – | Research and Diagnostic Systems R&D CBC-XR Hematology Control | registered |
| Bio-Rad Present in Europe in other categories | United States | Liquichek InteliQ Lyphochek VARIANT nbs Hemoglobin Variants System VARIANT nbs Newborn Screening | K171664 (2017) |
| Nova Biomedical Corp. | United States | STAT PROFILE NOVA NOVA/STAT PROFILE | registered |
| Remel Co. Present in Europe in other categories | United States | REMEL BACTIDROP | K960090 (1996) |
| Becton, Dickinson & CO Present in Europe in other categories | United States | BD BBL™ Gram Safranin BD BBL™ Gram Basic Fuchsin BD BBL™ Gram Crystal Violet BD BBL™ Gram Decolorizer BD BBL™ Gram Iodine (Stabilized) BD BBL™ TB Decolorizer | registered |
| DREW SCIENTIFIC, INC. | United Kingdom | Drew Scientific JAS Diagnostics Drew | registered |
| Scientific Device Laboratory, Inc. | United States | – | K884069 (1988) |
| Alpha-TEC Systems, Inc. | United States | Alpha-Tec Systems | K890861 (1989) |
| Fertipro NV Present in Europe in other categories | Belgium | LeucoScreen Plus Reagent 2 Spermac Stain - 4x 50ml Spermac Stain - Fix (50ml) LeucoScreen Plus Reagent 1 Spermac Stain - Stain A (250ml) Spermac Stain - Stain B (250ml) | registered |
| Primus Corp. | United States | Trinity Biotech | K955283 (1996) |
| 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) |
| Mechatronics USA LLC | – | Starrsed | registered |
| BIO SB, INC. Present in Europe in other categories | United States | TintoHematoxylin Automation Hematoxylin Counterstainer Pink Hematoxylin Counterstainer | registered |
| HORIBA INSTRUMENTS INCORPORATED | United States | DIFFTROL MINOTROL 16 Pointe Scientific, Inc. MINOTROL RETIC MINOTROL CRP | registered |
| Fisher Scientific Co., LLC | United States | Fisherbrand | K822352 (1982) |
| Phoenix Diagnostics, Inc. | United States | PHOENIX DIAGNOSTICS, INC. Phoenix Diagnostics | registered |
| Shenzhen YHLO Biotech Co., Ltd. Present in Europe in other categories | China | VISION ESR Analyzer | registered |
| BIOCARE MEDICAL LLC Present in Europe in other categories | – | Edgar Degas Eosin Rubens Eosin-Phloxine CAT Hematoxylin Tacha's Bluing Solution 10X Tacha's Bluing Solution ONCORE Pro Hematoxylin | registered |
| Helena Laboratories | United States | Plateletworks Arachidonic Acid Kit ADP Reagent Collagen Reagent Epinephrine Reagent Platelet Aggregation Kit Hemolysate Reagent | K192931 (2022) |
| IMMUNOTECH Present in Europe in other categories | United States | Beckman coulter Beckmancoulter | 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 |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Germiphene Corporation | Canada | Surgical Milk ET Foam | registered |
| Ventana Medical Systems, Inc. Present in Europe in other categories | United States | VENTANA HE 600 Eosin Giemsa Staining Kit VENTANA HE 600 Hematoxylin Elastic Stain Core Kit Hematoxylin II HEMATOXYLIN | registered |
| Hologic, Inc. Present in Europe in other categories | United States | ThinPrep | 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 Dade® Sickle-Trol Hemoglobin Controls | 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 |
| Sebia Present in Europe in other categories | United States | CAPILLARYS HEMOGLOBIN CAPILLARYS 3 DBS MINICAP HEMOGLOBIN CAPI 3 NEONAT Hb CAPILLARYS 3 DBS MICROPLATES CAPI 3 NEONAT HEMOLYSING SOLUTION | K232027 (2024) |
| TRANSENE COMPANY, INC. | – | Rowley Biochemical Harris Hematoxylin Rowley Biochemical Modified Orange G Rowley Biochemical Orange G Rowley Biochemical Scott's Water Rowley Biochemical EA Counterstain Rowley Biochemical Hydrochloric Acid 0.25% | registered |
| bioMerieux, Inc. Present in Europe in other categories | United States | PREVI® Color Gram RA1 ACETONE SAFRANIN solution PREVI® Color Gram RA3 ACETONE FUCHSIN solution PREVI® Color Gram RB IODINE solution PREVI® Color Gram RC CRYSTAL VIOLET solution PREVI® Color Gram RA4 FUCHSIN solution PREVI® Color Gram RA2 SAFRANIN solution | registered |
| Airscan, Inc. | United States | ESR STAT 6 HemaTechnologies ESR Control | registered |
| CLINICAL DIAGNOSTIC SOLUTIONS, INC. Present in Europe in other categories | United States | Boule Con-Diff Tri-Level CDS™ 3-PD Hematology Control CDS 3PD Hematology Control | K024173 (2003) |
| 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 |
| Protean Resources, LLC. | – | Chemical Service Labs, LLC | registered |
| DiaSpect Medical GmbH Present in Europe in other categories | – | DiaSpect Control Pack HBT4 DiaSpect Control Pack HBT3 DiaSpect Control Pack HBT2 DiaSpect Control Pack HBT1 | 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 |
| Meridian Bioscience, Inc. Present in Europe in other categories | United States | Trichrome Stain Para-Pak TRICHROME STAIN Trichrome Blue Stain | registered |
| Microbiologics, Inc. Present in Europe in other categories | United States | India Ink | registered |
| Microgenics Corporation Present in Europe in other categories | United States | Hema-Trol | registered |
| DRUCKER DIAGNOSTICS Present in Europe in other categories | United States | QBC Diagnostics | registered |
| KOROS U.S.A., INC. | United States | Needle Holder | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| SURE-TECH DIAGNOSTIC ASSOCIATES, INC. | United States | ST 201-C Fetal Hemoglobin Control ST 201 Fetal Hemoglobin Control ST 201-B Fetal Hemoglobin Control | 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 |
| Fisher Diagnostics | United States | Thermo Scientific Nerl® Thermo Scientific Protocol™ Parasitology System | registered |
| HAMILTON THORNE, INC. | United States | IVOS CEROS | registered |
| Incell Corporation, LLC | United States | ZAPR™ | registered |
| M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. Present in Europe in other categories | – | QwikCheck Vitality Kit QwikCheck DFI Kit | registered |
| Quantimetrix Corp. | United States | Spinalscopics Control Level 1 Set 3x3mL Spinalscopics Control Level 2 Set 3x3mL | K010598 (2001) |
| Sarstedt Aktiengesellschaft & Co.KG | – | Sediplus® S 200, 12 V DC Sediplus® S 2000 NX | registered |
| Shenzhen Dakewe Bio-engineering Co., Ltd Present in Europe in other categories | China | BioSci™ | registered |
| VITRO SA Present in Europe in other categories | Spain | Contrast Hematolxylin HDH3 | 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 |
| Biobase Biodustry(Shandong)Co., Ltd. | China | BIOBASE | registered |
| Cytovale Inc | – | IntelliSep Quality Control Kit | registered |
| DRG Instruments Gesellschaft mit beschränkter Haftung | – | Histamine ELISA | registered |
| DRG International Inc | United States | Histamine ELISA | registered |
| GERMAINE LABORATORIES, INC | United States | AIMSTRIP HEMOGLOBIN CONTROL SET | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| Immunostics Company, Inc | United States | hemochroma PLUS Control | registered |
| Nidacon International AB | Sweden | Nidacon | registered |
| Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories | United States | VITROS | registered |
| STERILE SAFEQUIP & CHEMICALS LLP | – | ZBT-ESR | 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 |
| ACON Laboratories, Inc. | United States | – | registered |
| AD Supply Group Limited | United Kingdom | – | registered |
| AMERICAN NATIONAL RED CROSS HEADQUARTERS | United States | – | registered |
| AVE Science & Technology Co., Ltd Present in Europe in other categories | China | – | registered |
| Agilent Technologies, Inc. Present in Europe in other categories | United States | – | registered |
| Antibodies, Inc. | United States | – | registered |
| Azer Scientific, Inc. | United States | – | registered |
| BIOCHECK, INC. | United States | – | registered |
| BIOGENEX LABORATORIES | United States | – | registered |
| BIT Group France | France | – | registered |
| Bio-Rad Laboratories (Bio-Rad Services France) Present in Europe in other categories | France | – | registered |
| Biocare Corp. Present in Europe in other categories | United States | – | registered |
| Bionostics, Inc. | United States | – | registered |
| CHEMICAL SERVICE LABS, LLC | United States | – | registered |
| CITOTEST LABWARE MANUFACTURING CO., LTD. Present in Europe in other categories | China | – | registered |
| COPAN ITALIA SPA Present in Europe in other categories | Italy | – | registered |
| CalibreScientific US, Inc. Present in Europe in other categories | United States | – | registered |
| Cancer Diagnostics, Inc. | United States | – | registered |
| Chaptec America | Canada | – | registered |
| Citotest Scientific Co.,Ltd. Present in Europe in other categories | China | – | registered |
| Cliniqa Corporation | United States | – | registered |
| Creative Waste Solutions, Inc. | United States | – | registered |
| DAGATRONICS CORPORATION Present in Europe in other categories | South Korea | – | registered |
| Delasco, LLC | 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 |
| ENG Scientific, LLC | United States | – | registered |
The 100 most active manufacturers are shown, out of 165.
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