Haematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)Coagulation factors

Fibrinogen assays (factor i)

EMDN code W0103020201

45 manufacturers, 145 models including 141 on the market, 15 countries

On the market in Models on the market only Manufacturer country

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Manufacturers registered in Europe (EUDAMED) 45

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
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	Fibrinogen (Fb)Test Kit (Immunoturbidimetric) Calibrator：1mL×1(91036)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) Quality Control：1mL×1(92031)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×1 R2:6mL×1(702)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4(707)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4(709)98/79 26 others Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（710）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（796）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:40ml×3 R2:20ml×2（704）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（705）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（713）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（715）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（716）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（791）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（793）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（798）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:32ml×1（792）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60ml ×1 R2:20ml×1（703）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2(701)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（706）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（794）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60ml×6 R2:60ml×2（795）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:90ml×1 R2:30ml×1（708）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Calibration plasma: 0.5mL×1（511001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Calibration plasma: 1.0mL×1（511002）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried： Reagent:2.5mL×5, Diluent:50mL×2（502001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried：Reagent:1mL×10,Diluent:50mL×2（503001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried：Reagent:2mL×5, Diluent:50mL×2（501001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (abnormal): 0.5mL×1（521002）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (abnormal): 1.0mL×1（521004）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (normal): 0.5mL×1（521001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (normal): 1.0mL×1（521003）98/79	– 98/79	EUDAMED record Report an error
Sanymed	Italy	Coag Cal - Coagulazione CAL / Coagulation CAL Coagulation R1: 6x1ml (Lyophilized)98/79 Coag Ctrl H - Coagulazione CTRL H / Coagulation CTRL H Coagulation R1: 6x1ml (Lyophilized)98/79 Coag Ctrl N - Coagulazione CTRL N / Coagulation CTRL N Coagulation R1: 6x1ml (Lyophilized)98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) Bulk R1:1000mL98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) MULTI-PURPOSE KIT R1:2x20mL98/79 10 others FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) SA1500/2500 R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) SA2000 R1:2x20mL - 140 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) SA3500/4500/330 R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) Sphera R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (RID) RID R1: 1x15 Test98/79 FIB Cal - Fibrinogeno CAL / Fibrinogen CAL MULTI-PURPOSE KIT CAL: 3x0,5mL (Lyophilized)98/79 FIB Ctrl - Fibrinogeno CTRL 2Liv. / Fibrinogen CTRL 2 Lev. MULTI-PURPOSE KIT CTL1: 2x1,5mL + CTL2: 2x0,7mL (Lyophilized)98/79 Fib-C - Fibrinogeno Clauss / Fibrinogen Clauss (Clauss) Coagulation R1:3x3mL + CAL: 1x1ml + CTRL:1x1mL + DIL: 1x9mL (Lyophilized)98/79 Im - Imidazolo / Imidazole (for Fibrinogen) Coagulation R1: 2x50ml98/79 KAO - Caolino / Kaolin (for Fibrinogen) Coagulation R1: 8x1ml98/79	– 98/79	Website info@sanymed.it EUDAMED record Report an error
Dymind EU representative : Eunitor GmbH (Germany)	China	Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) Specification 1 :R1 2.0 mL× 10, R2 5.0 mL×122 refs98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) Specification 2 :R1 4.0 mL× 10, R2 30.0 mL× 52 refs98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 1 test/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 10 tests/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 15 tests/kit98/79 6 others Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 30 tests/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 1.0 mL× 1098/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 1.0 mL× 10, R2: 5.0 mL× 698/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 2.0 mL× 1098/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 4.0 mL× 1, R2: 30.0 mL× 198/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 4.0 mL× 1098/79	– 98/79	regulationdept@dymind.com EUDAMED record Report an error
Medcaptain FDA EU representative : R Sight B.V. (Netherlands)	China	Fibrinogen Assay MCC00501E98/79 Fibrinogen Assay MCC00502E98/79 Fibrinogen Assay MCC00513E98/79 Fibrinogen Assay MCC00514E98/79 Fibrinogen Assay MCC00515E98/79 5 others Fibrinogen Assay MCC00516E98/79 Functional Fibrinogen Assay MCT00601E98/79 Functional Fibrinogen Assay MCT00602E98/79 Functional Fibrinogen Assay MCT00603E98/79 Functional Fibrinogen Assay MCT01501E3 refs	C IVDR, 98/79	Website info@medcaptain.com EUDAMED record Report an error
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other	China	Fibrinogen Detection Kit (Coagulation Assay)3 refs Fibrinogen Detection Kit (Coagulation Assay) FIB Fluid Reagent: 10×10mL, OVB Buffer: 4×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Fluid Reagent: 10×2mL, OVB Buffer: 2×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Fluid Reagent: 10×5mL, OVB Buffer: 2×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Reagent: 10×2.2mL, FIB Reconstitution fluid: 1×30mL, FIB Buffer: 1×51mL98/79 3 others Fibrinogen Detection Kit (Coagulation Assay) FIB Reagent: 10×5mL, FIB Reconstitution fluid: 1×51mL, FIB Buffer: 2×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Reagent: 10×5mL, FIB Reconstitution fluid: 1×51mL, FIB Buffer: 2×51mL, Calibrator: 1×1mL98/79 R: 10×2.2mL; FIB Buffer: 1×51mL; FIB Reconstitution Fluid: 1×30mL; Calibrator: 1×1mL98/79	C IVDR, 98/79	EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	R1: 1mL×5, R2: 100mL×1, R3: 1mL×198/79 R1: 1mL×5, R2: 50mL×1, R3: 1mL×198/79 R1:2ml×5,R2:100ml×1,R3:1ml×12 refs98/79 R1:4mlx5,R2:100ml×1,R3:1ml×198/79 R1:4mL×5,R2:100mL×1,R3:1mL×198/79 1 other R1:8mL×5,R2:100mL×2,R3:1mL×12 refs98/79	– 98/79	Website support@rayto.com EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA	Germany	Antiserum to Human Fibrinogen IVDR_27_MAR EB_C_REAG_AS_FIB Dade Fibrinogen Determination Reagents IVDR_27_MAR EB_C_KIT_Fib_Determ_Reag3 refs Dade Thrombin Reagent IVDR_27_MAR EB_C_REAG_Thromb_Reag3 refs Multifibren U IVDR_27_MAR EB_C_REAG_Multifib_U3 refs N Antiserum to Human Fibrinogen IVDR_27_MAR EB_C_REAG_N_AS_FIB	C IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Instrumentation Laboratory FDA EU representative : Instrumentation Laboratory SpA (Italy)	United States	HemosIL Fibrinogen-C 0020301100 HemosIL Fibrinogen-C XL 0020003900 HemosIL Q.F.A. Thrombin (Bovine) 0020301700 HemosIL Q.F.A. Thrombin (Bovine) 0020301800	B IVDR	Website Regulatory@werfen.com EUDAMED record Report an error
Egyptian For Biotechnology-Spectrum Diagnostics EU representative : MDSS GmbH (Germany)	Egypt	FIBRINOGEN 590 00198/79 Fibrinogen-LS Clauss Clotting Time Method 631 00198/79 Fibrinogen-LS Clauss Clotting Time Method 631 00298/79	– 98/79	Website info@spectrum-diagnostics.com EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany)	Egypt	FIBRINOGEN98/79 FIBRINOGEN Immuno - Turbidimetry98/79 FIBRINOGEN-LS Clauss Clotting Time Method2 refs98/79	– 98/79	Website EUDAMED record Report an error
Stago FDA	France	STA® - Fibrinogen 5 STA® - Liquid Fib sthemO Fib M	B IVDR	EUDAMED record Report an error
Steellex EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	R1:510ml R2:330ml98/79 R1:52ml R2:330ml98/79 R1:55ml R2:330ml98/79	– 98/79	info@steellex.com EUDAMED record Report an error
Technoclone	Austria	Fibrinogen C Fibrinogen Reagent98/79 Fibrinogen Reagent Kit98/79	C IVDR, 98/79	Website regulatory@technoclone.com EUDAMED record Report an error
Erba	Czechia	Erba Thrombin Reagent 1098/79 Erba Thrombin Reagent 2098/79	– 98/79	Website EUDAMED record Report an error
Horiba FDA	France	Yumizen G FIB 2 130003638398/79 Yumizen G FIB 5 130003638498/79	– 98/79	EUDAMED record Report an error
Linear FDA	Spain	Cromatest98/79 Fibrinogen98/79	– 98/79	Website info@linear.es EUDAMED record Report an error
Sclavo	Italy	Sclavo Fibrinogen Kit K2905376298/79 Sclavo Fibrinogen Kit K2905376598/79	– 98/79	qa@sclavo.it EUDAMED record Report an error
Tcoag FDA	Ireland	TriniCLOT Fibrinogen 6 mL98/79 TriniCLOT Fibrinogen Kit98/79	– 98/79	Website EUDAMED record Report an error
Wiener Laboratorios SAIC FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Argentina	Fibrinogen98/79 Fibrinógeno98/79	– 98/79	Website marketing@wiener-lab.com EUDAMED record Report an error
Zybio FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Fibrinogen (FIB) Kit (Immunoturbidimetric Method)98/79 Fibrinogen Reagent Kit (Clotting Method)3 refs	C IVDR, 98/79	PMS@zy-ivd.com EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruHemo98/79	– 98/79	EUDAMED record Report an error
Biolabo	France	BE FIB Thrombin Kaolin + Buffer Fibrinogen Reagents3 refs	B IVDR	support@biolabo.fr EUDAMED record Report an error
Biosystems FDA	Spain	FIBRINOGEN3 refs98/79	– 98/79	Website EUDAMED record Report an error
C.P.M. Compagnia Per La Medicina	Italy	Fibrinogen‐ONE I021798/79	– 98/79	Website EUDAMED record Report an error
Chronolab	Spain	Fibrinogen, R1 8 x 2 mL, R2 1 x 100 mL, R3 1 x 3.5 mL98/79	– 98/79	Website info@chronolab.com EUDAMED record Report an error
Diagnostics	Belgium	Fibrinogen HC0030098/79	– 98/79	Website EUDAMED record Report an error
Fisher Diagnostics A division of Fisher Scientific EU representative : B·R·A·H·M·S GmbH (Germany)	United States	100607, J10060798/79	– 98/79	Website EUDAMED record Report an error
Fortress Diagnostics	Northern Ireland	Fibrinogen (L.S) Immunoturbidimetric, Multipoint BXC0442A98/79	– 98/79	Website info@fortressdiagnostics.com EUDAMED record Report an error
Human	Germany	HemoStat Fibrinogen98/79	– 98/79	Website EUDAMED record Report an error
HYPHEN BioMed FDA	France	FIBRIPHEN™ LRT3 refs	C IVDR	Website info@hyphen-biomed.com EUDAMED record Report an error
Kalians EU representative : MDSS GmbH (Germany)	Egypt	Fibrinogen-LS Clauss Clotting Time Method98/79	– 98/79	EUDAMED record Report an error
Maccura EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Fibrinogen (Fib)4 refs98/79	– 98/79	Website EUDAMED record Report an error
MedicalSystem Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands)	China	Fibrinogen Kit (Immunoturbidimetric Method) 60ml（R1:1×45ml+R2:1×15ml）98/79	– 98/79	EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Fibrinogen (FIB) Assay Kit (Clotting Method) 105-023622-00、105-023623-00、105-023624-00、105-023625-00、105-023626-00、105-023627-003 refs	C IVDR	Website EUDAMED record Report an error
Nordic Biomarker	Sweden	MRX Fib Clauss98/79	– 98/79	Website info@nordicbiomarker.com EUDAMED record Report an error
Quimica Clinica Aplicada	Spain	FIBRINÓGENO98/79	– 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 Fibrinogen (Clotting Assay)10 refs98/79	– 98/79	Website EUDAMED record Report an error
Spinreact	Spain	FIBRINOGEN2 refs98/79	– 98/79	Website EUDAMED record Report an error
Syscanbio EU representative : Obelis s.a. (Belgium)	China	Thrombin Reagent (for Fbg assay) Coagulation Analyzer3 refs98/79	– 98/79	EUDAMED record Report an error
TECO Medical Instruments, Production + Trading	Germany	TEClot FIB2 refs98/79	– 98/79	Website info@teco-medical.com EUDAMED record Report an error
Wondfo FDA EU representative : QbD RepS BV (Belgium)	China	Fibrinogen Reagent Kit (Clotting) W48298/79	– 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
Yhlo Biotech (Nanjing) EU representative : Medunion S.L. (Spain)	China	Fibrinogen (FIB) Assay Kit (Immunoturbidimetric Method)2 refs98/79	– 98/79	EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	China	Reagent 1：5×5 mL Reagent 2：5×5 mL Dilution：2×5 mL98/79 (no longer marketed) Reagent：5×5 mL Buffer：5×10 mL98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Ns Biotec EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	Egypt	Fibrinogen Fib-M-050198/79 (no longer marketed)	– 98/79	Website info@nsbiotec.com EUDAMED record Report an error
Vitro Scient EU representative : MDSS GmbH (Germany) No model still on the market	Egypt	Fibrinogen 20 Tests - 3040198/79 (no longer marketed)	– 98/79	Website info@vitroscient.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.

Other manufacturers known in the United States (FDA) 6

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
Helena Laboratories	United States	Helena Fibrinogen Calibrator Helena Thrombin Reagent Fibrinogen Assay Kit	K841020 (1984)
Bio/Data Corp. Present in Europe in other categories	United States	Calcium Chloride	K812108 (1981)
Fisher Diagnostics	United States	Thermo Scientific Pacific Hemostasis®	registered
R 2 DIAGNOSTICS, INC. Present in Europe in other categories	United States	Fibrotek	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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