ReagentsHaematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)
General coagulation tests
EMDN code W01030201
Manufacturers registered in Europe (EUDAMED) 52
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 26
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 |
|---|---|---|---|
| Roche Diagnostics Corp. Present in Europe in other categories | United States | CoaguChek XS Plus Professional Care Kit CoaguChek XS Patient Self Testing Care Kit CoaguChek XS PT strips CoaguChek XS Pro Kit CoaguChek XS Professional Use Care Kit CoaguChek Vantus | K253188 (2025) |
| Nova Biomedical Corp. | United States | STAT PROFILE | K961938 (1996) |
| Fisher Diagnostics | United States | Thermo Scientific Pacific Hemostasis® | registered |
| Helena Laboratories | United States | APTT-SA (Soluble Activator) Reagent Kit 0.25 M Calcium Chloride AB-TROL 2 Coagulation Control Thrombin Clotting Time Reagent Thromboplastin-LI Reagent Kit | K951820 (1995) |
| Biomedica Diagnostics Inc | Canada | QuikCoag APTT-EA QuikCoag Calcium Choride 0.02M QuikCoag Calcium Chloride 0.02M QuikCoag PT-HS | registered |
| Abbott Point of Care, Inc. Present in Europe in other categories | United States | i-STAT i-STAT PTplus Control Level 1 i-STAT PTplus Control Level 2 i-STAT PTplus Cartridge | registered |
| Precision Biologic Present in Europe in other categories | Canada | CRYOcheck Hex LA CRYOcheck™ Platelet Lysate | K193556 (2020) |
| ACCRIVA DIAGNOSTICS HOLDINGS, INC. Present in Europe in other categories | United States | Hemochron Whole Blood Microcoagulation System | registered |
| IDG/SANZAY Corporation | – | IDG/Sanzay | registered |
| Biomedica ADI Inc. | – | ACTICLOT Protein C Resistance Kit ACTICLOT dPT | registered |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | Xprecia Stride™ Coagulation Analyzer Xprecia™ System PT/INR Strips | K151964 (2016) |
| UNIVERSAL BIOSENSORS PTY LTD | Australia | Xprecia Prime™ Coagulation Analyzer Xprecia Prime™ PT/INR Test Strips | K230802 (2024) |
| Analytical Control Systems, Inc. | United States | Slide Platelet Aggregation Test Reagent | K961892 (1997) |
| CORGENIX MEDICAL CORPORATION | – | REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit (96 Well) | registered |
| Abbott Laboratories Present in Europe in other categories | United States | – | K220282 (2023) |
| Cliniqa Corporation | United States | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Dylan Lucas International Inc | Canada | – | registered |
| Hemagen Diagnostics, Inc. | United States | – | registered |
| High Technology, Inc. Present in Europe in other categories | United States | – | registered |
| IKOR Sistemas Electronicos, SL | Spain | – | registered |
| Keypar Limited | United Kingdom | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | registered |
| VEENAK INTERNATIONAL LIMITED | United Kingdom | – | registered |
| i-SENS, Inc. Present in Europe in other categories | South Korea | – | registered |
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- Parent category : Haemostasis reagents (coagulation)207 manufacturers