BIOKIT S.A.: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
Família Alinity c IgE 80146502331	Immunoglobulin E	II	ABBOTT LABORATORIOS DO BRASIL LTDA	04/03/2021	Valid
HemosIL AcuStar Von Willebrand Factor Collagen Binding Activity 80003610598	Von Willebrand factor	II	WERFEN MEDICAL LTDA	17/12/2020	Valid
Família Alinity c LP 80146502264	Lipoprotein	II	ABBOTT LABORATORIOS DO BRASIL LTDA	20/07/2020	Valid
Alinity c Proteins Control Kit 80146502254	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	15/06/2020	Valid
Alinity c Proteins Standard 80146502248	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	16/03/2020	Valid
Família Alinity c ASO 80146502244	Antistreptolysin	II	ABBOTT LABORATORIOS DO BRASIL LTDA	10/02/2020	Valid
Alinity c A1-Antitrypsin Reagent Kit 80146502239	Alpha-1 antitrypsin	II	ABBOTT LABORATORIOS DO BRASIL LTDA	16/12/2019	Valid
Alinity c A-1-AGP Reagent Kit 80146502235	Alpha-1 acid glycoprotein (AGP)	II	ABBOTT LABORATORIOS DO BRASIL LTDA	18/11/2019	Valid
Família Alinity c ASO-RF Control Kit I e Control Kit II 80146502231	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	04/11/2019	Valid
Família HemosIL HIT-Ab 80003610568	Coagulation factor IV	II	WERFEN MEDICAL LTDA	08/04/2019	Valid
Família HemosIL FDP 80003610521	Fibrinogen/fibrin degradation products (FDP)	II	WERFEN MEDICAL LTDA	02/05/2017	Valid
BIO-FLASH Triggers 80003610305	Buffers, diluents and other solutions for laboratory analysis	I	WERFEN MEDICAL LTDA	26/03/2012	Valid
BIO-FLASH 80003610246	Immunoassay instrument	II	WERFEN MEDICAL LTDA	01/02/2010	Valid
QUANTIA Lp(a) CONTROLS / QUANTIA Lp(a) CONTROLES 80146501637	Lipoprotein	II	ABBOTT LABORATORIOS DO BRASIL LTDA	28/12/2009	Valid
QUANTIA Lp(a) STANDARD / QUANTIA Lp(a) PADRÃO 80146501638	Lipoprotein	II	ABBOTT LABORATORIOS DO BRASIL LTDA	28/12/2009	Valid
QUANTIA Lp(a) REAGENTS / QUANTIA Lp(a) REAGENTES 80146501639	Lipoprotein	II	ABBOTT LABORATORIOS DO BRASIL LTDA	28/12/2009	Valid
Quantia IgE Standard / Quantia IgE Padrão 80146501615	Immunoglobulin E	II	ABBOTT LABORATORIOS DO BRASIL LTDA	19/10/2009	Valid
Quantia IgE Reagents / Quantia IgE Reagentes 80146501618	Immunoglobulin E	II	ABBOTT LABORATORIOS DO BRASIL LTDA	19/10/2009	Valid
Quantia ASO Control II / Controle II ASO 80146501598	Antistreptolysin	II	ABBOTT LABORATORIOS DO BRASIL LTDA	31/08/2009	Valid
QUANTIA Proteins Standard / Calibrador das Proteínas A1AGP e A1ATP 80146501599	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	31/08/2009	Valid
Quantia ASO Control I / Controle I ASO 80146501600	Antistreptolysin	II	ABBOTT LABORATORIOS DO BRASIL LTDA	31/08/2009	Valid
Quantia ASO Standard / Calibrador ASO 80146501573	Antistreptolysin	II	ABBOTT LABORATORIOS DO BRASIL LTDA	19/01/2009	Valid
Quantia A-1-AGP / A-1-glicoproteína ácida Reagente 80146501574	Alpha-1 acid glycoprotein (AGP)	II	ABBOTT LABORATORIOS DO BRASIL LTDA	19/01/2009	Valid
Quantia ASO / Antiestreptolisina-O ASO Reagente 80146501575	Antistreptolysin	II	ABBOTT LABORATORIOS DO BRASIL LTDA	19/01/2009	Valid

BIOKIT S.A.

Brazilian registration holders

Device types

Registrations