INSTRUMENTATION LABORATORY COMPANY: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
Família ACL Elite 80003610601	Hemostasis analyzer	II	WERFEN MEDICAL LTDA	22/04/2021	Valid
Gem Hematocrit Evaluator 80003610423	Combined parameters in one product - class II	II	WERFEN MEDICAL LTDA	22/09/2014	Valid
Cartuchos Gem Premier 4000 Pak com IQM – BG/HCT/LYTES/COOX 80003610363	Combined parameters in one product - class II	II	WERFEN MEDICAL LTDA	21/10/2013	Valid
Hemosil PT Fibrinogênio HS Plus 80003610362	Fibrinogen	II	WERFEN MEDICAL LTDA	29/07/2013	Valid
Hemosil Von Willebrand Fator Atividade 80003610361	Von Willebrand factor	II	WERFEN MEDICAL LTDA	08/07/2013	Valid
Hemosil QFA Trombina 80003610357	Fibrinogen	II	WERFEN MEDICAL LTDA	01/07/2013	Valid
Hemosil Proteína S Livre 80003610346	Free protein S	II	WERFEN MEDICAL LTDA	13/05/2013	Valid
Gem CVP 4 80003610324	Bilirubin	II	WERFEN MEDICAL LTDA	04/02/2013	Valid
Hemosil Proteína S Atividade 80003610323	Protein S	II	WERFEN MEDICAL LTDA	21/01/2013	Valid
Hemosil Plasma de Calibração 80003610321	Combined parameters in one product - class II	II	WERFEN MEDICAL LTDA	31/12/2012	Valid
Hemosil Controle Baixo de Fibrinogênio 80003610313	Fibrinogen	II	WERFEN MEDICAL LTDA	24/12/2012	Valid
Hemosil Von Willebrand Fator Ristocetina Cofator Atividade 80003610314	Von Willebrand factor	II	WERFEN MEDICAL LTDA	24/12/2012	Valid
Contril 9 Multipack 80003610319	Combined parameters in one product - class II	II	WERFEN MEDICAL LTDA	24/12/2012	Valid
HemosIL LA Positive Control 80003610308	Lupus anticoagulant (LA)	II	WERFEN MEDICAL LTDA	14/05/2012	Valid
HemosIL dRVVT Screen 80003610306	Lupus anticoagulant (LA)	II	WERFEN MEDICAL LTDA	30/04/2012	Valid
HemosIL dRVVT Confirm 80003610307	Lupus anticoagulant (LA)	II	WERFEN MEDICAL LTDA	30/04/2012	Valid
HemosIL Controle Baixo e Alto de LMW Heparina 80003610264	Heparin	II	WERFEN MEDICAL LTDA	14/06/2010	Valid
FAMÍLIA GEM CVP 4000 (PRODUTOS DE AVALIAÇÃO DE CALIBRAGEM) WERFEN MEDICAL LTDA 80003610191	Combined parameters in one product - class II	II	WERFEN MEDICAL LTDA	29/09/2008	Valid
GEM PREMIER 4000 Plus 80003610184	Analyzer for general chemistry, hormones, drugs or proteins	II	WERFEN MEDICAL LTDA	14/04/2008	Valid
HEMOSIL ANTITROBINA LIQUIDA 80003610162	Antithrombin	II	WERFEN MEDICAL LTDA	23/04/2007	Valid
HEMOSIL TEMPO DE COAGULACAO DE SILICA 80003610158	Lupus anticoagulant (LA)	II	WERFEN MEDICAL LTDA	22/01/2007	Valid
FAMILIA DE CONTROLES UNI OU MULTIPARÂMETROS-HEMOSIL ENSAIO DE CONTROLE ANORMAL ALTO E BAIXO - WERFEN 80003610113	Combined parameters in one product - class II	II	WERFEN MEDICAL LTDA	31/12/2004	Valid

INSTRUMENTATION LABORATORY COMPANY

Brazilian registration holders

Device types

Registrations