Haematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)Haemostasis calibrators/controls

Calibration plasma for haemostasis

EMDN code W0103020701

30 manufacturers, 128 models including 128 on the market, 15 countries

On the market in Models on the market only Manufacturer country

Export to CSV

Manufacturers registered in Europe (EUDAMED) 30

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.

Manufacturer	Country	Registered models	Class	Contact
Technoclone	Austria	AK-Calibrant98/79 APIX CalSet Ceveron TGA CAL98/79 Coagulation Reference2 refs DABI CalSet 25 others EDOX CalSet RIVA CalSet Technochrom FVIII:C 2G CAL Technoclot PT Owren capillary CAL set Technofluor ADAMTS13:Act 0 CAL TECHNOLEIA D-Dimer Calibrator 0 ng/mL98/79 TECHNOLEIA D-Dimer Calibrator ~3000 ng/mL98/79 Technoview Apixaban CAL98/79 Technoview Argatroban CAL98/79 Technoview Arixtra CAL Technoview Dabigatran CAL98/79 Technoview Edoxaban CAL98/79 Technoview LMWH CAL Technoview Orgaran CAL Technoview Rivaroxaban CAL98/79 Technoview UFH CAL TECHNOZYM ADAMTS13 Activity CAL Set98/79 TECHNOZYM ADAMTS13 Antigen CAL Set98/79 TECHNOZYM ADAMTS13 CAL Set98/79 TECHNOZYM ADAMTS13 INH CAL Set98/79 TECHNOZYM PAI-1 Actibind CAL Set98/79 TECHNOZYM PAI-1 Antigen CAL Set98/79 TECHNOZYM t-PA EDTA CAL Set98/79 TECHNOZYM vWF:Ag CAL Set98/79 TECHNOZYM vWF:CBA CAL Set98/79	C IVDR, 98/79	Website regulatory@technoclone.com EUDAMED record Report an error
Stago FDA	France	Etaloquick®98/79 STA® - Apixaban Calibrator STA® - Dabigatran Calibrator STA® - Edoxaban Calibrator STA® - FDP Calibrator98/79 11 others STA® - FM Calibrator STA® - Hepanorm® HBPM/LMWH98/79 STA® - Multi Hep Calibrator STA® - Unicalibrator STA® - VWF:Ag Calibrator98/79 STG® - Cal&Fluo98/79 sthemO FDP cal sthemO Heparin cal sthemO Unical sthemO VWF cal Unicalibrator98/79	B, C IVDR, 98/79	EUDAMED record Report an error
Dymind EU representative : Eunitor GmbH (Germany)	China	Antithrombin Ⅲ Calibrator Model：CAL AT-III 1× 1.0 mL/kit98/79 Antithrombin Ⅲ Calibrator Model：CAL AT-III 6× 1.0 mL/kit98/79 D-Dimer Calibrator Model : CAL-DD 1×0.5 mL/kit (volume after reconstitution)98/79 D-Dimer Calibrator Model : CAL-DD 6×0.5 mL/kit (volume after reconstitution)98/79 D-Dimer Calibrator Model : CAL-DD 6×1.0 mL/kit (volume after reconstitution)98/79 8 others Fibrin and Fibrinogen Degradation Products Calibrator CAL-FDP,Calibrator 1: 1 × 1.0 mL，Calibrator 2: 1 ×1.0 mL，Calibrator 3: 1 × 1.0 mL，Calibrator 4: 1 × 1.0 mL，Calibrator 5: 1 × 1.0 Ml98/79 Fibrin and Fibrinogen Degradation Products Calibrator CAL-FDP,Calibrator 1: 2 × 1.0 mL，Calibrator 2: 2 × 1.0 mL，Calibrator 2: 2 × 1.0 mL，Calibrator 3: 2 × 1.0 mL，Calibrator 4: 2 × 1.0 mL，Calibrator 5: 2 ×1.0 mL98/79 Fibrin and Fibrinogen Degradation Products Calibrator CAL-FDP,Calibrator 5: 3 × 1.0 mL98/79 Fibrin and Fibrinogen Degradation Products Calibrator CAL-FDP，Calibrator 5: 1 × 1.0 mL98/79 Fibrinogen Calibrator CAL-FIB：1 × 1.0 mL/kit98/79 Fibrinogen Calibrator Model : CAL-FIB Specification 2:6×1.0 mL/kit98/79 Heparin Calibrator CAL Anti-Xa Specification 1：Calibrator 1: 1 ×1.0 mL；Calibrator 2: 1 ×1.0 mL；Calibrator 3: 1 ×1.0 mL98/79 Protein C Calibrator CAL-PC Specification 1：1×0.5 mL/kit (reconstituted volume)98/79	– 98/79	regulationdept@dymind.com EUDAMED record Report an error
Nordic Biomarker	Sweden	D-Dimer Calibrator K50452 refs MRX Antithrombin Calibrator98/79 MRX D-dimer DDU Calibrator MRX FDP Clear Calibrator Set98/79 MRX Fib Clauss Calibrator98/79 4 others MRX Free Protein S Calibrator98/79 MRX Protein C Calibrator98/79 MRX PT Quick (INR) Calibrator Set98/79 MRX vWF Antigen Calibrator98/79	C IVDR, 98/79	Website info@nordicbiomarker.com EUDAMED record Report an error
HYPHEN BioMed FDA	France	BIOPHEN™ Apixaban Calibrator3 refs BIOPHEN™ Arixtra® Calibrator Fondaparinux Calibrator2 refs BIOPHEN™ Edoxaban Calibrator3 refs BIOPHEN™ Heparin Calibrator2 refs BIOPHEN™ Orgaran® Calibrator Danaparoid Calibrator2 refs 2 others BIOPHEN™ Rivaroxaban Calibrator Low3 refs BIOPHEN™ UFH Calibrator	C IVDR	Website info@hyphen-biomed.com EUDAMED record Report an error
Instrumentation Laboratory FDA EU representative : Instrumentation Laboratory SpA (Italy)	United States	HemosIL Apixaban Calibrators 0020014200 HemosIL Calibration Plasma 0020003700 HemosIL Dabigatran Calibrators 0020013400 HemosIL Heparin Calibrators 0020300600 HemosIL ISI Calibrate 0020010600 1 other HemosIL Rivaroxaban Calibrators 0020013600	C IVDR	Website Regulatory@werfen.com EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA	Germany	Dabigatran Standards IVDR_27_MAR EB_C_REAG_Dabi_Stand2 refs Fibrinogen Calibrator Kit IVDR_27_MAR EB_C_KIT_Fib_Cal2 refs INNOVANCE Apixaban Standards IVDR_27_MAR EB_C_INN_Riva_Stand3 refs INNOVANCE Heparin Calibrator IVDR_27_MAR EB_C_REAG_INN_Hep_Cal2 refs PT Multi-Calibrator IVDR_27_MAR EB_C_PROF_KIT_PT-Multi_Cal2 refs 1 other Standard Human Plasma IVDR_27_MAR EB_C_PROF_REAG_SHP3 refs	C IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Medcaptain FDA EU representative : R Sight B.V. (Netherlands)	China	Coagulation Calibrators MCH01701E98/79 Coagulation Calibrators MCH01706E98/79 Coagulation Calibrators MCH01707E98/79 Coagulation Calibrators MCH01708E98/79 Coagulation Calibrators MCH01709E98/79	– 98/79	Website info@medcaptain.com EUDAMED record Report an error
Maccura EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	D-Dimer Calibrator EBL218100598/79 D-Dimer Calibrator EBL218200598/79 D-Dimer Calibrator EBL218300598/79 Fibrinogen Degradation Product (FDP) Calibrator98/79	– 98/79	Website EUDAMED record Report an error
Biosystems FDA	Spain	D-DIMER CONTROLS I / II98/79 D-DIMER STANDARD98/79 FIBRINOGEN STANDARD98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Hemolumi Coagulation Calibrators4 refs98/79 Hemolumi D-Dimer Calibrators4 refs98/79 Hemolumi FDP Calibrators4 refs98/79	– 98/79	Website EUDAMED record Report an error
Tcoag FDA	Ireland	TriniCAL Fibrinogen98/79 TriniCAL PC/PS98/79 TriniCAL Reference Plasma98/79	– 98/79	Website EUDAMED record Report an error
Biolabo	France	BE Cal Ref Reference Plasma2 refs BE Cal Set Calibration Plasma PT Prothrombin Time Standard Set2 refs	B, C IVDR	support@biolabo.fr EUDAMED record Report an error
Erba	Czechia	Erba PT - INR Multical98/79 Erba Standard Plasma98/79	– 98/79	Website EUDAMED record Report an error
r2 Diagnostics FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	United States	Emicizumab Calibrator98/79 FibroTek Fibrinogen kit98/79	– 98/79	Website qa@r2diagnostics.com EUDAMED record Report an error
Spinreact	Spain	COAGULATION CAL No98/79 D-DIMER CAL 098/79	– 98/79	Website EUDAMED record Report an error
TECO Medical Instruments, Production + Trading	Germany	TECal DD98/79 TECal N98/79	– 98/79	Website info@teco-medical.com EUDAMED record Report an error
Chronolab	Spain	Coagulation calibrator, 4 x 1 mL98/79	– 98/79	Website info@chronolab.com EUDAMED record Report an error
Diagnostics	Belgium	Calibrator Fibr/PT HC0060098/79	– 98/79	Website EUDAMED record Report an error
Diazyme FDA EU representative : MDSS GmbH (Germany)	United States	Diazyme D-Dimer Calibrator Set98/79	– 98/79	Website EUDAMED record Report an error
Dirui FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	DIRUI CAL1：1×0.5mL CAL2：1×0.5mL CAL3：1×0.5mL CAL4：1×0.5mL CAL5：1×0.5mL CAL6：1×0.5mL98/79	– 98/79	EUDAMED record Report an error
Horiba FDA	France	Yumizen G CAL 1300036416	C IVDR	EUDAMED record Report an error
Human	Germany	HemoStat Calibrator98/79	– 98/79	Website EUDAMED record Report an error
Medical & Biological Laboratories EU representative : QbD RepS BV (Belgium)	Japan	HEXAMATE Factor XIII - Calibrator	B IVDR	EUDAMED record Report an error
Nihon Kohden FDA EU representative : NIHON KOHDEN EUROPE GmbH (Germany)	Japan	"D-dimer Calibrator DD-CAL"	C IVDR	Website information@db.nkc.co.jp EUDAMED record Report an error
Precision BioLogic FDA EU representative : Emergo Europe B.V. (Netherlands)	Canada	CRYOcheck2 refs	C IVDR	EUDAMED record Report an error
Sclavo	Italy	K2900518598/79	– 98/79	qa@sclavo.it EUDAMED record Report an error
Syscanbio EU representative : Obelis s.a. (Belgium)	China	Fibrinogen Reference Plasma Coagulation Analyzer STD-FIB-0198/79	– 98/79	EUDAMED record Report an error
Thermofisher FDA	Finland	D-Dimer Calibration Set	C IVDR	Website EUDAMED record Report an error
Wiener Laboratorios SAIC FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Argentina	Coagulation Calibrator2 refs98/79	– 98/79	Website marketing@wiener-lab.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.

Didn't find it?

Related categories