Haematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)General coagulation tests
Prothrombin time ( quick test )
EMDN code W0103020101
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 |
|---|---|---|---|
| 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 |
| 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 |
| Biomedica Diagnostics Inc | Canada | QuikCoag PT-HS | registered |
| ACCRIVA DIAGNOSTICS HOLDINGS, INC. Present in Europe in other categories | United States | Hemochron Whole Blood Microcoagulation System | registered |
| Helena Laboratories | United States | Thromboplastin-LI Reagent Kit | K951820 (1995) |
| IDG/SANZAY Corporation | – | IDG/Sanzay | 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) |
| Biomedica ADI Inc. | – | ACTICLOT dPT | 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 |
| 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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