SIEMENS HEALTHCARE DIAGNIOSTICS INC.: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
ADVIA CHEMISTRY GLUCOSE HEXOQUINASE_3, concentrada (GLUC_c) 10345161970	Glucose	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	20/10/2015	Valid
Família de controles ADVIA 360 Controle 10345161966	Combined parameters in one product - class II	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	14/09/2015	Valid
ADVIA 360/560 Calibrador 10345161967	Combined parameters in one product - class II	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	14/09/2015	Valid
Dimension Amonia Flex 10345161934	Ammonia	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	22/12/2014	Valid
SISTEMA RAPIDLAB 348EX 10345161930	Analyzer for blood gases, ions or pH	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	24/11/2014	Valid
Material de controle de qualidade do ADVIA Centaur cHIV 10345161862	HIV-1/HIV-2 antibody	IV	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	04/02/2013	Until 04/02/2028
Calibrador de Enzimas II Dimension 10345161845	Alanine aminotransferase (ALT/GPT)	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	02/04/2012	Valid
MÓDULO DE CENTRIFUGAÇÃO 10345169003	Centrifuge	I	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	22/02/2011	Valid
Diluente ADVIA Centaur eE2 10345161775	Buffers, diluents and other solutions for laboratory analysis	I	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	03/11/2010	Valid
DIMENSION EXL 200 10345161762	Analyzer for general chemistry, hormones, drugs or proteins	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	16/08/2010	Valid
REAGENTE FLEX DE PESQUISA DE BARBITURATO NA URINA – DIMENSION 10345161735	Barbiturates	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	17/05/2010	Valid
HEMATEK SLIDE STAINER 10345161656	Sample preparation and processing instrument - pre-analytical phase	I	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	30/11/2009	Valid
Rapidlab 1200® Na+/K+/Ca++/Cl- Electrode Fill 10345161659	Solution for performance testing of equipment components	I	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	30/11/2009	Valid
ADVIA 2120 / 2120I HEMATOLOGY SYSTEMS 10345161654	Cell and platelet analyzer or counter	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	29/10/2009	Valid
EMIT TOX ENSAIO DE ANTIDEPRESSIVOS TRICICLICOSSERICOS 10345161143	Tricyclic antidepressants	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	10/08/2009	Valid
CALIBRADOR DA TIREÓIDE DIMENSION 10345161203	Combined parameters in one product - class II	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	10/08/2009	Valid
SYVA RAPIDTEST D.A.U ANFETAMINAS (AMP) 10345161209	Amphetamine	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	10/08/2009	Valid
REAGENTE FLEX DE PESQUISA DE CANABINOIDES NA URINA DIMENSION 10345161229	Cannabinoids	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	10/08/2009	Valid
REAGENTE DE PROTEINA TOTAL TP DIMENSION 10345161348	Total protein	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	10/08/2009	Valid
CALIBRADOR DE TBI / DBI - DIMENSION® 10345161044	Bilirubin	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	29/12/2008	Valid
REAGENTE DE BILIRRUBINA DIRETA (DBI) REVISADA - DIMENSION® 10345161046	Bilirubin	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	29/12/2008	Valid
REAGENTE DE BILIRRUBINA TOTAL (TBI) REVISADA - DIMENSION® 10345161047	Bilirubin	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	29/12/2008	Valid
ADVIA CENTAUR CP R1/R2 ACID/BASE REAGENTS 10345160634	Buffers, diluents and other solutions for laboratory analysis	I	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	03/09/2007	Valid
QC HBsAg ADVIA CENTAUR 10345160590	Hepatitis B surface antigen (HBsAg)	IV	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	09/07/2007	Until 09/07/2027
QC HCV CENTAUR 10345160591	Total antibody to hepatitis C virus (anti-HCV)	IV	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	09/07/2007	Until 09/07/2027
QC HBc IgM ADVIA CENTAUR 10345160596	IgM antibody to hepatitis B core antigen (anti-HBc IgM)	IV	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	09/07/2007	Until 09/07/2027
QC HBcT ADVIA CENTAUR 10345160597	Total antibody to hepatitis B core antigen (anti-HBc)	IV	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	09/07/2007	Until 09/07/2027
ADVIA CHEMISTRY APO A1/B CALIBRATOR (APO A1/B-CAL) 10345160557	Combined parameters in one product - class II	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	02/07/2007	Valid
ADVIA CHEMISTRY RHEUMATOID FACTOR REAGENTS (RF) 10345160562	Rheumatoid factor	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	02/07/2007	Valid
ADVIA CHEMISTRY IgG_2 REAGENTS (IgG_2) 10345160564	Immunoglobulin G	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	02/07/2007	Valid
ADVIA CHEMISTRY DIRECT LDL CHOLESTEROL REAGENTS (D-LDL) 10345160575	Low-density lipoprotein (LDL)	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	02/07/2007	Valid
ADVIA CHEMISTRY WIDE RANGE C-REACTIVE PROTEIN CALIBRATORS (wCRP - CAL) 10345160580	C-reactive protein (CRP)	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	02/07/2007	Valid
ADVIA CHEMISTRY TOTAL BILIRUBIN REAGENTS 2 10345160473	Bilirubin	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	07/05/2007	Valid
FAMÍLIA ADVIA 120 TESTPOINT 3 IN 1 HEMATOLOGY CONTROLES NORMAL/ABNORMAL 1/ABNORMAL 2 - BAYDIAG 10345160476	Combined parameters in one product - class II	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	07/05/2007	Valid
RAPIDLAB 1200 SERIES REAGENT CARTRIDGE 10345160477	Solution for performance testing of equipment components	I	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	07/05/2007	Valid
QC RUB G ADVIA CENTAUR 10345160290	Rubella virus	III	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	05/12/2002	Until 05/12/2027

SIEMENS HEALTHCARE DIAGNIOSTICS INC.

Brazilian registration holders

Device types

Registrations