ReagentsHaematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)
Coagulation inhibitors/thrombophilia markers
EMDN code W01030206
Manufacturers registered in Europe (EUDAMED) 44
- 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) 22
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 |
|---|---|---|---|
| Helena Laboratories | United States | Lyophilized Platelets von Willebrand Factor Antigen ELISA Kit (96 tests) Factor XII Deficient Substrate Plasma Factor VII Deficient Substrate Plasma Tris-Buffered Saline Factor V Deficient Substrate Plasma | K952668 (1996) |
| IMMUCOR GTI DIAGNOSTICS, INC. Present in Europe in other categories | United States | Factor VIII Antibody Screen PF4 Enhanced® PF4 IgG Anti-Human IgG/A/M Conjugate Specimen Diluent PF4 Concentrated Wash (10x) | K201570 (2020) |
| Precision Biologic Present in Europe in other categories | Canada | CRYOcheck™ Clot C™ CRYOcheck Factor VIII Chromogenic CRYOcheck Chromogenic Factor IX C & S Diluent CRYOcheck™ FVIII Inhibitor Kit CRYOcheck™ LA Check™ | K251440 (2025) |
| Biomedica ADI Inc. | – | ACTICLOT C KIT IMUBIND vWF ACTIVITY ELISA ACTICLOT PROTEIN S IMUBIND PLASMA PAI-1 ELISA SPECTROLYSE PAI-1 DVVconfirm 5 | registered |
| Chrono-Log Corp. Present in Europe in other categories | United States | Chrono-log | K945414 (1995) |
| CORGENIX MEDICAL CORPORATION | – | REAADS von Willebrand Factor Antigen Test Kit REAADS von Willebrand Factor Activity Test Kit REAADS Protein S Antigen Test kit REAADS Monoclonal Free Protein S Antigen REAADS Protein C Test Kit | registered |
| Instrumentation Laboratory CO Present in Europe in other categories | United States | HemosIL CL HIT-IgG (PF4-H) HemosIL AcuStar HIT-IgG (PF4-H) HemosIL HIT-Ab(PF4-H) | K170854 (2017) |
| Kent Laboratories, Inc. | United States | Antithrombin III RID plate package Antiserum to Human Antithrombin III | K831961 (1983) |
| AKERS BIOSCIENCES, INC. | United States | PIFA PLUSS® PF4 Rapid Assay PIFA® Heparin/PF4 Rapid Assay | registered |
| Affinity Biologicals, Inc. | Canada | VisuLize Factor FVIII Antigen Kit VisuLize Factor FIX Antigen Kit | K052825 (2006) |
| Ramco Laboratories, Inc. | United States | VFE | K983107 (1998) |
| THE BINDING SITE GROUP LIMITED Present in Europe in other categories | United States | Human Antithrombin III BINDARID™ Radial Immunodiffusion Kit | K913667 (1992) |
| BIT Analytical Solutions GmbH | Germany | – | registered |
| Beckman Coulter, Inc. Present in Europe in other categories | United States | – | registered |
| Biomedica Diagnostics Inc | Canada | – | registered |
| Corgenix, Inc. | United States | – | K032139 (2004) |
| Dsrv, Inc. | United States | – | K132076 (2014) |
| IMMUCOR, INC. Present in Europe in other categories | United States | – | registered |
| Instrumentation Laboratory (IL) Co. Present in Europe in other categories | United States | – | K243374 (2025) |
| Rossix AB Present in Europe in other categories | Sweden | – | registered |
| Siemens Healthcare Diagnostic Products GmbH Present in Europe in other categories | Germany | – | K242952 (2025) |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | – | K081769 (2009) |
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.
Related categories
- Fibrinolysis132 manufacturers
- Haemostasis rapid tests - RT & POC56 manufacturers
- Coagulation factors53 manufacturers
- General coagulation tests52 manufacturers
- Haemostasis calibrators/controls45 manufacturers
- Special coagulation tests31 manufacturers
- Auxiliary reagents and supplements (haemostasis)20 manufacturers
- Platelet factors13 manufacturers
- Haemostasis reagents - other9 manufacturers
- Parent category : Haemostasis reagents (coagulation)207 manufacturers