Manufacturer

Nordic Biomarker

SwedenLegal entities : Nordic Biomarker AB

Markets : Sweden

Approvals : EU – class A, C

16 categories, 36 models including 36 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Calibration plasma for haemostasis	W0103020701	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	EUDAMED record Report an error
Control plasma for haemostasis	W0103020702	Control Level 12 refs Control Level 22 refs D-Dimer Control High SC109K D-Dimer Control Low SC108K MRX Specialty Abnormal Control 1 other MRX Specialty Normal Control	C IVDR	EUDAMED record Report an error
Buffers (haemostasis)	W0103020903	D-Dimer PBS Diluent2 refs MRX Laboratory Water MRX PT Buffer3 refs MRX Sample Diluent2 refs	A IVDR	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer Latex LRT3 refs MRX Blue D-dimer MRX Green D-dimer	C IVDR	EUDAMED record Report an error
Free protein s antigen	W0103020612	MRX Blue Free Protein S98/79 MRX Red Free Protein S98/79	– 98/79	EUDAMED record Report an error
Haemostasis controls - other	W0103020799	MRX FDP Clear High Control98/79 MRX FDP Clear Low Control98/79	– 98/79	EUDAMED record Report an error
Activated partial thromboplastin time	W0103020102	MRX APTT2 refs	C IVDR	EUDAMED record Report an error
Antithrombin	W0103020602	MRX Antithrombin98/79	– 98/79	EUDAMED record Report an error
Calcium chloride	W0103020901	MRX Calcium Chloride3 refs	A IVDR	EUDAMED record Report an error
Coagulation factor von willebrand (ag)	W0103020215	MRX Green vWF Antigen98/79	– 98/79	EUDAMED record Report an error
Fibrinogen assays (factor i)	W0103020201	MRX Fib Clauss98/79	– 98/79	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	MRX Green FDP98/79	– 98/79	EUDAMED record Report an error
General coagulation tests - other	W0103020199	MRX PT Owren3 refs	C IVDR	EUDAMED record Report an error
Protein c	W0103020607	MRX Protein C98/79	– 98/79	EUDAMED record Report an error
Prothrombin time ( quick test )	W0103020101	MRX PT Quick98/79	– 98/79	EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time	W0103020103	MRX Thrombin Time98/79	– 98/79	EUDAMED record Report an error

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