Haematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)Haemostasis calibrators/controls
Control plasma for haemostasis
EMDN code W0103020702
Manufacturers registered in Europe (EUDAMED) 44
- 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) 43
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 |
|---|---|---|---|
| George King Bio-Medical, Inc. | United States | George King Factor VIII Deficient Plasma with Inhibitor George King Factor XIII Deficient Plasma George King Positive Lupus Anticoagulant George King von Willebrand Plasma, Type 2A George King von Willebrand Plasma Type 3 George King von Willebrand Plasma Type 1 | K161316 (2017) |
| ACCRIVA DIAGNOSTICS HOLDINGS, INC. Present in Europe in other categories | United States | Hemochron Whole Blood Coagulation System directCHECK Whole Blood Controls HepCheck Whole Blood Control directCHECK ACT-LR Whole Blood Control, Level 2 directCHECK ACT+ Whole Blood Control Level 1 directCHECK ACT+ Whole Blood Control, Level 2 | registered |
| Bio-Rad Present in Europe in other categories | United States | Lyphochek Liquichek | K040275 (2004) |
| Fisher Diagnostics | United States | Thermo Scientific Pacific Hemostasis® | K010750 (2001) |
| Tem Innovations GmbH Present in Europe in other categories | Germany | ROTEM® | registered |
| Lgc Clinical Diagnostics, Inc. Present in Europe in other categories | United States | Validate | registered |
| Biomedica ADI Inc. | – | LAtrol ABNORMAL CONTROL PLASMA ACTICLOT Protein C Resistance control plasmas LAtrol NORMAL CONTROL PLASMA ACTICHROME HEPARIN (ANTI-FXA) ACTICHROME Heparin (Anti-FIIa) | registered |
| Eurotrol B.V. Present in Europe in other categories | Netherlands | CueSee® Coag | registered |
| Medtronic, Inc. Present in Europe in other categories | United States | – | K103314 (2010) |
| Abbott Point of Care, Inc. Present in Europe in other categories | United States | i-STAT | registered |
| Helena Laboratories | United States | Coagulation S.A.C.-2 (Specialty Assay Control) AB-Trol 3 Coagulation Control Coagulation S.A.R.P (Specialty Assayed Reference Plasma) Coagulation S.A.C.-1 (Specialty Assay Control) | K100103 (2010) |
| Biomedica Diagnostics Inc | Canada | QuikCoag Control Level 3 High Abnormal QuikCoag Control Level 1 Normal QuikCoag Control Level 2 Low Abnormal | registered |
| AKERS BIOSCIENCES, INC. | United States | Heparin/PF4 Antibody Serum Panel | K052697 (2006) |
| CORGENIX MEDICAL CORPORATION | – | REAADS Coagulation Control 2 REAADS Coagulation Control 1 | registered |
| Haemonetics Corp. Present in Europe in other categories | United States | Haemonetics TEG 6s | registered |
| IDG/SANZAY Corporation | – | IDG/Sanzay | registered |
| Kamiya Biomedical Co. Present in Europe in other categories | United States | K-ASSAY® Fibrinogen Control K-ASSAY® D-Dimer Control | registered |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | Xprecia Stride™ Coagulation Analyzer Xprecia™ System PT Controls | registered |
| 5-Diagnostics Ltd | Switzerland | 5-PLASMA Bivalirudin Control | registered |
| Analytical Control Systems, Inc. | United States | Animal Plasma Control Level II | K894425 (1989) |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | CoaguChek XS Pro PT controls | K063823 (2007) |
| Takeda Pharmaceuticals U.S.A., Inc. Present in Europe in other categories | United States | Recombinant Factor VIII Substrate, Porcine Sequence | registered |
| UNIVERSAL BIOSENSORS PTY LTD | Australia | Xprecia™ Systems PT Controls | registered |
| Aalto Scientific, Ltd. | United States | – | K100716 (2011) |
| Abbott Laboratories Present in Europe in other categories | United States | – | registered |
| Affinity Biologicals, Inc. | Canada | – | K150144 (2016) |
| Biokit, S.A. Present in Europe in other categories | Spain | – | registered |
| Bionostics, Inc. | United States | – | registered |
| Cliniqa Corporation | United States | – | K120900 (2013) |
| Dsrv, Inc. | United States | – | registered |
| Hart Biologicals Ltd Present in Europe in other categories | United Kingdom | – | registered |
| High Technology, Inc. Present in Europe in other categories | United States | – | registered |
| Infitek Co., Ltd. Present in Europe in other categories | China | – | registered |
| Invetech Pty Ltd | Australia | – | registered |
| KMC Systems | United States | – | registered |
| Labpeak Co.,Ltd | China | – | registered |
| Maine Standards Company, LLC | United States | – | K170864 (2017) |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| SHIMA LABORATORIES CO., LTD. | Japan | – | registered |
| STS Corporation | United States | – | registered |
| Scitek Global Co.,Ltd | China | – | registered |
| Siemens Healthcare Diagnostics Prodcts GmbH | Germany | – | K162540 (2017) |
| Technoclone Herstellung v. Diagnostika u. Arzneimitteln GmbH | Austria | – | registered |
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