ReagentsHaematology / haemostasis / immunohaematology / histology / cytologyHaematology reagents
Haematology controls and calibrators
EMDN code W01030105
Manufacturers registered in Europe (EUDAMED) 49
- 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) 31
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 Meter Trax | K091303 (2010) |
| Nova Biomedical Corp. | United States | STAT PROFILE NOVA NOVA/STAT PROFILE | registered |
| DREW SCIENTIFIC, INC. | United Kingdom | Drew Scientific Drew | registered |
| HORIBA INSTRUMENTS INCORPORATED | United States | DIFFTROL MINOTROL 16 Pointe Scientific, Inc. MINOTROL RETIC MINOTROL CRP | registered |
| Becton, Dickinson & CO Present in Europe in other categories | United States | BD Multi-Check BD Leucocount Reticcount BD Trucount™ | 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) |
| Advanced Instruments, Inc. Present in Europe in other categories | United States | Advanced Instruments GloCyte® Controls Kit Advanced Instruments GloCyte® High Level Control Vial (Single) Advanced Instruments GloCyte® Low Level Control Vial (Single) Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit | registered |
| Airscan, Inc. | United States | HemaTechnologies ESR Control | 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 |
| Microgenics Corporation Present in Europe in other categories | United States | Hema-Trol | registered |
| Primus Corp. | United States | Trinity Biotech | 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 |
| DRUCKER DIAGNOSTICS Present in Europe in other categories | United States | QBC Diagnostics | registered |
| Quantimetrix Corp. | United States | Spinalscopics Control Level 1 Set 3x3mL Spinalscopics Control Level 2 Set 3x3mL | K010598 (2001) |
| Cytovale Inc | – | IntelliSep Quality Control Kit | 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 |
| Siemens Healthcare Diagnostics Products GmbH Present in Europe in other categories | Germany | Dade® Sickle-Trol Hemoglobin Controls | registered |
| ACON Laboratories, Inc. | United States | – | registered |
| Bionostics, Inc. | United States | – | registered |
| Boditech Med Inc. Present in Europe in other categories | South Korea | – | registered |
| Boule Diagnostics AB Present in Europe in other categories | Sweden | – | registered |
| HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical | United States | – | registered |
| MARKEN HEALTHTECH LIMITED | India | – | registered |
| Mark Enterprises | India | – | registered |
| STANBIO LABORATORY, L.P. | United States | – | registered |
| STS Corporation | United States | – | registered |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | registered |
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