Haematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)General coagulation tests
Activated partial thromboplastin time
EMDN code W0103020102
Manufacturers registered in Europe (EUDAMED) 41
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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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) 14
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 |
|---|---|---|---|
| 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 | K935169 (1994) |
| Biomedica Diagnostics Inc | Canada | QuikCoag APTT-EA QuikCoag Calcium Choride 0.02M QuikCoag Calcium Chloride 0.02M | 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 |
| Analytical Control Systems, Inc. | United States | Slide Platelet Aggregation Test Reagent | K961892 (1997) |
| Biomedica ADI Inc. | – | ACTICLOT Protein C Resistance Kit | registered |
| CORGENIX MEDICAL CORPORATION | – | REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit (96 Well) | registered |
| IDG/SANZAY Corporation | – | IDG/Sanzay | registered |
| Pentapharm AG Present in Europe in other categories | United States | Pefakit | K042762 (2004) |
| Hemagen Diagnostics, Inc. | United States | – | registered |
| High Technology, Inc. Present in Europe in other categories | United States | – | registered |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | – | registered |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | registered |
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