ReagentsHaematology / haemostasis / immunohaematology / histology / cytologyHaematology reagents
Cellular stains for microscopy
EMDN code W01030103
Manufacturers registered in Europe (EUDAMED) 39
- 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) 81
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 |
|---|---|---|---|
| Remel Co. Present in Europe in other categories | United States | REMEL BACTIDROP | K960090 (1996) |
| Scientific Device Laboratory, Inc. | United States | – | K884069 (1988) |
| Alpha-TEC Systems, Inc. | United States | Alpha-Tec Systems | K890861 (1989) |
| 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 |
| 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 |
| BIO SB, INC. Present in Europe in other categories | United States | TintoHematoxylin Automation Hematoxylin Counterstainer Pink Hematoxylin Counterstainer | registered |
| Fisher Scientific Co., LLC | United States | Fisherbrand | K822352 (1982) |
| 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 |
| 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 |
| 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 |
| Protean Resources, LLC. | – | Chemical Service Labs, LLC | 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 |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Abbott Laboratories Present in Europe in other categories | United States | Alinity | registered |
| HORIBA ABX SAS Present in Europe in other categories | France | ABX RETIX (0.5L) ABX FLUOCYTE (0.5L) | registered |
| M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. Present in Europe in other categories | – | QwikCheck Vitality Kit QwikCheck DFI Kit | 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 |
| DRG Instruments Gesellschaft mit beschränkter Haftung | – | Histamine ELISA | registered |
| DRG International Inc | United States | Histamine ELISA | registered |
| Fisher Diagnostics | United States | Thermo Scientific Protocol™ Parasitology System | registered |
| IMMUNOTECH Present in Europe in other categories | United States | Beckmancoulter | registered |
| Nidacon International AB | Sweden | Nidacon | registered |
| AD Supply Group Limited | United Kingdom | – | registered |
| AVANTOR PERFORMANCE MATERIALS, LLC Present in Europe in other categories | 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 |
| Azer Scientific, Inc. | United States | – | registered |
| B&E BIO-TECHNOLOGY CO., LTD. Present in Europe in other categories | China | – | registered |
| BIOCHECK, INC. | United States | – | registered |
| BIOGENEX LABORATORIES | United States | – | registered |
| Beckman Coulter, Inc. Present in Europe in other categories | United States | – | registered |
| Biocare Corp. Present in Europe in other categories | United States | – | registered |
| CHEMICAL SERVICE LABS, LLC | United States | – | registered |
| CITOTEST LABWARE MANUFACTURING CO., LTD. Present in Europe in other categories | China | – | 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 |
| Creative Waste Solutions, Inc. | United States | – | registered |
| DAGATRONICS CORPORATION Present in Europe in other categories | South Korea | – | registered |
| Delasco, LLC | United States | – | registered |
| E K INDUSTRIES, INC. | United States | – | registered |
| ENG Scientific, LLC | United States | – | registered |
| Epredia Holdings Ltd. | United States | – | registered |
| Ethos Biosciences | United States | – | registered |
| Fertility Solutions, Inc. | United States | – | registered |
| HARDY DIAGNOSTICS | United States | – | registered |
| Halotech DNA | Spain | – | registered |
| Hangzhou HealthSky Biotechnology Co., Ltd. Present in Europe in other categories | China | – | registered |
| JAMES ALEXANDER CORP. | United States | – | registered |
| Jinan Babio Biotechnology Co., Ltd. | China | – | registered |
| Leica Biosystems, division of Leica Microsystems, Inc. | United States | – | registered |
| MEDICAL CHEMICAL CORPORATION | United States | – | registered |
| MEDICAL ELECTRONIC SYSTEMS LTD. Present in Europe in other categories | Israel | – | registered |
| MEDITE Medical GmbH Present in Europe in other categories | Germany | – | registered |
| Merck Life Science KGaA | Germany | – | registered |
| MilliporeSigma | United States | – | registered |
| Newcomer Supply Inc | United States | – | registered |
| Noul Co., Ltd. Present in Europe in other categories | South Korea | – | registered |
| PathnSitu Biotechnologies Pvt Ltd | India | – | registered |
| Platinum Focus Group Ltd. | United Kingdom | – | registered |
| Polysciences, Inc. | United States | – | registered |
| RICCA CHEMICAL COMPANY LLC | United States | – | registered |
| ROCKY MOUNTAIN REAGENTS, INC. | United States | – | registered |
| RR Donnelley Global Turnkey Solutions | United States | – | registered |
| Radiation Products Design, Inc. | United States | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| SLMP LLC (STATLAB MEDICAL PRODUCTS) Present in Europe in other categories | United States | – | registered |
| SSN Solutions | United States | – | registered |
| Silgan Unicep | United States | – | registered |
| TECO DIAGNOSTICS | United States | – | registered |
| TRANSENE CO INC DBA ROWLEY BIOCHEMICAL INC | United States | – | registered |
| VECTOR SURGICAL, LLC Present in Europe in other categories | United States | – | registered |
| VOLUSOL | United States | – | registered |
| VPIX Medical, Inc. Present in Europe in other categories | South Korea | – | registered |
| Wuhan Landing Intelligence Medical Co.,Ltd Present in Europe in other categories | China | – | registered |
| Zhejiang GENE SCIENCE Co., Ltd | China | – | registered |
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