INSTRUMENTATION LABORATORY CO.: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
HemosIL AcuStar Von Willebrand Factor Antigen 80003610596	Von Willebrand factor	II	WERFEN MEDICAL LTDA	17/12/2020	Valid
HemosIL AcuStar Von Willebrand Factor Ristocetin Cofactor Activity 80003610597	Von Willebrand factor	II	WERFEN MEDICAL LTDA	17/12/2020	Valid
Família HemosIL AcuStar Anti-Cardiolipin IgM 80003610599	Anticardiolipin	II	WERFEN MEDICAL LTDA	17/12/2020	Valid
Família HemosIL AcuStar Anti-Cardiolipin IgG 80003610600	Anticardiolipin	II	WERFEN MEDICAL LTDA	17/12/2020	Valid
HemosIL AcuStar HIT Controls 80003610594	Heparin	II	WERFEN MEDICAL LTDA	12/11/2020	Valid
HemosIL AcuStar HIT-IgG (PF4-H) 80003610595	Anti-platelet antibody	II	WERFEN MEDICAL LTDA	12/11/2020	Valid
Família GEM ChemSTAT critPVP 80003610590	Combined parameters in one product - class II	II	WERFEN MEDICAL LTDA	29/10/2020	Valid
Família GEM ChemSTAT CVP 3 e 4 80003610591	Creatinine	II	WERFEN MEDICAL LTDA	29/10/2020	Valid
Família GEM ChemSTAT PVP 80003610592	Combined parameters in one product - class II	II	WERFEN MEDICAL LTDA	29/10/2020	Valid
Família ChemSTAT Hematocrit Evaluator 80003610593	Blood cell count	II	WERFEN MEDICAL LTDA	29/10/2020	Valid
Família ChemSTAT System Evaluator 80003610589	Combined parameters in one product - class II	II	WERFEN MEDICAL LTDA	22/10/2020	Valid
Família GEM ChemSTAT CVP 1 e CVP 2 80003610588	Combined parameters in one product - class II	II	WERFEN MEDICAL LTDA	01/10/2020	Valid
GEM Premier ChemSTAT PAK 80003610586	Combined parameters in one product - class III	III	WERFEN MEDICAL LTDA	28/09/2020	Until 28/09/2030
GEM Premier ChemSTAT PAK 80003610587	Combined parameters in one product - class III	III	WERFEN MEDICAL LTDA	28/09/2020	Until 28/09/2030
Família HemosIL Dabigatran 80003610585	Thrombin inhibitor	II	WERFEN MEDICAL LTDA	21/09/2020	Valid
HemosIL AcuStar ADAMTS13 Activity 80003610578	ADAMTS13 (von Willebrand factor-cleaving protease)	II	WERFEN MEDICAL LTDA	03/08/2020	Valid
HemosIL AcuStar von Willebrand Factor Controls 80003610579	Von Willebrand factor	II	WERFEN MEDICAL LTDA	03/08/2020	Valid
HemosIL AcuStar Triggers 80003610574	Buffers, diluents and other solutions for laboratory analysis	I	WERFEN MEDICAL LTDA	18/06/2020	Valid
HEMOHUB 80003619005	Software	II	WERFEN MEDICAL LTDA	29/10/2019	Valid
Família HemosIL Fatores 80003610571	Coagulation factor V	II	WERFEN MEDICAL LTDA	21/10/2019	Valid
Família Hemosil Apixaban 80003610569	Heparin	II	WERFEN MEDICAL LTDA	09/09/2019	Valid
GEMWEB PLUS 500 80003619004	Software	II	WERFEN MEDICAL LTDA	26/08/2019	Valid
GEM Premier 5000 80003610558	Analyzer for blood gases, ions or pH	II	WERFEN MEDICAL LTDA	09/04/2018	Valid
GEM Premier 5000 PAK com iQM2 80003610542	Combined parameters in one product - class III	III	WERFEN MEDICAL LTDA	26/12/2017	Until 26/12/2027
Família ACL TOP Série 50 80003610512	Hemostasis analyzer	II	WERFEN MEDICAL LTDA	03/11/2015	Valid
ACL AcuStar 80003610506	Immunoassay instrument	II	WERFEN MEDICAL LTDA	29/06/2015	Valid
Hemosil Plasmin Inhibitor 80003610501	Alpha-2 antiplasmin (plasmin inhibitor)	II	WERFEN MEDICAL LTDA	08/06/2015	Valid
Hemosil Factor VIII Deficient Plasma 80003610450	Coagulation factor-deficient plasma	II	WERFEN MEDICAL LTDA	22/12/2014	Valid
Hemosil Tempo de Trombina 80003610322	Thrombin time (TT)	II	WERFEN MEDICAL LTDA	31/12/2012	Valid
HemosIL LA Negative Control 80003610310	Lupus anticoagulant (LA)	II	WERFEN MEDICAL LTDA	28/05/2012	Valid
HEMOSIL SYNTHASIL 80003610285	Activated partial thromboplastin time (aPTT)	III	WERFEN MEDICAL LTDA	13/06/2011	Until 13/06/2036
PLASMA DEFICIENTE EM FATORES DE COAGULAÇÃO 80003610279	Coagulation factor-deficient plasma	II	WERFEN MEDICAL LTDA	26/07/2010	Valid
Família HemosIL Controle Baixo e Alto de UF Heparina 80003610265	Heparin	II	WERFEN MEDICAL LTDA	14/06/2010	Valid
Hemosil Especial Teste Nível II 80003610202	Combined parameters in one product - class II	II	WERFEN MEDICAL LTDA	25/02/2009	Valid
HEMOSIL ANTITROMBINA LIQUIDA 80003610166	Antithrombin	II	WERFEN MEDICAL LTDA	14/05/2007	Valid
HEMOSIL CONTROLES DE HOMOCISTEINA 80003610163	Homocysteine	II	WERFEN MEDICAL LTDA	30/04/2007	Valid
FAMILIA ACL 80003610138	Analyzer for general chemistry, hormones, drugs or proteins	II	WERFEN MEDICAL LTDA	20/03/2006	Valid
IL TESTE PLASMA REAGENTE FATOR V RESISTENCIA DOFATOR V a APC 80003610051	Coagulation factor V	II	WERFEN MEDICAL LTDA	10/02/2004	Valid

INSTRUMENTATION LABORATORY CO.

Brazilian registration holders

Device types

Registrations