SENTINEL CH. SPA: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
FOB Gold NG Wide 80856940013	Fecal occult blood	III	BELCHER FARMACEUTICA DO BRASIL LTDA ME	20/07/2026	Until 20/07/2036
Família Alinity c Cystatin C 80146502423	Cystatin C	II	ABBOTT LABORATORIOS DO BRASIL LTDA	18/05/2026	Valid
Família ACE 80146502419	Angiotensin	II	ABBOTT LABORATORIOS DO BRASIL LTDA	04/05/2026	Valid
Família ACE for Alinity 80146502420	Angiotensin	II	ABBOTT LABORATORIOS DO BRASIL LTDA	04/05/2026	Valid
Família Sangue Oculto FOB Gold (Sentinel) 80856940012	Fecal occult blood	III	BELCHER FARMACEUTICA DO BRASIL LTDA ME	16/06/2025	Until 16/06/2035
Família CALiaGold Sentinel 80856940008	Calprotectin	II	BELCHER FARMACEUTICA DO BRASIL LTDA ME	07/04/2025	Valid
Diluente CALiaGold Sentinel 80856940009	Buffers, diluents and other solutions for laboratory analysis	I	BELCHER FARMACEUTICA DO BRASIL LTDA ME	07/04/2025	Valid
Família Tubos de Coleta Linha Gold Sentinel 80856940010	Container or material for collection, storage or transport of biological samples	I	BELCHER FARMACEUTICA DO BRASIL LTDA ME	07/04/2025	Valid
Diluente FOB Gold Sentinel 80856940011	Buffers, diluents and other solutions for laboratory analysis	I	BELCHER FARMACEUTICA DO BRASIL LTDA ME	07/04/2025	Valid
Família Clin Chem Control 10345162518	Combined parameters in one product - class II	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	13/01/2025	Valid
SENTiFIT 270 Analyzer 80856940007	Analyzer for general chemistry, hormones, drugs or proteins	II	BELCHER FARMACEUTICA DO BRASIL LTDA ME	23/12/2024	Valid
Família HbA1c – Hemoglobina Glicada Sentinel 80856940006	Glycated hemoglobin (HbA1c)	II	BELCHER FARMACEUTICA DO BRASIL LTDA ME	28/08/2023	Valid
Atellica CH Cobre (Cu) 10345162432	Copper	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	11/03/2022	Valid
Família Atellica CH Enzima Conversora de Angiotensina (ECA) 10345162434	Angiotensin	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	11/03/2022	Valid
Família Lipase NG OC 80146502341	Lipase	II	ABBOTT LABORATORIOS DO BRASIL LTDA	30/09/2021	Valid
Aldolase 10345162403	Aldolase	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	01/07/2021	Valid
Família de Reagente, Calibrador e Controle Fructosamine Sentinel 10033121019	Fructosamine	II	BECKMAN COULTER DO BRASIL COMÉRCIO E IMPORTAÇÃO DE PRODUTOS DE LABORATÓRIO LTDA	27/05/2021	Valid
Família Ácido Bílico Total (TBA) 10345162385	Bile acids	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	21/09/2020	Valid
Família Frutosamina 10345162367	Fructosamine	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	27/07/2020	Valid
Alinity c Kappa Light Chains Reagent Kit 80146502255	Kappa/lambda light chains	II	ABBOTT LABORATORIOS DO BRASIL LTDA	15/06/2020	Valid
Alinity c Cholinesterase 80146502249	Cholinesterase	II	ABBOTT LABORATORIOS DO BRASIL LTDA	16/03/2020	Valid
Alinity c Ceruloplasmin Reagent Kit 80146502245	Ceruloplasmin	II	ABBOTT LABORATORIOS DO BRASIL LTDA	26/02/2020	Valid
Immuno Control Set 10345162349	Combined parameters in one product - class II	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	27/01/2020	Valid
Família Alinity c Ammonia Ultra 80146502238	Ammonia	II	ABBOTT LABORATORIOS DO BRASIL LTDA	16/12/2019	Valid
Familia Antiestreptolisina O (ASO) 10345162340	Antistreptolysin	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	18/11/2019	Valid
Família Beta 2 Micro Latex CN 10345162341	Beta-2 microglobulin - tumor marker	III	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	18/11/2019	Until 29/06/2036
Alinity c HBDH Reagent Kit 80146502232	Hydroxybutyrate dehydrogenase (HBDH)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	18/11/2019	Until 24/11/2035
Alinity c Dibucaine CHE Reagent Kit 80146502233	Dibucaine cholinesterase	II	ABBOTT LABORATORIOS DO BRASIL LTDA	18/11/2019	Valid
Alinity c Pancreatic Amylase Reagent Kit 80146502234	Amylase	II	ABBOTT LABORATORIOS DO BRASIL LTDA	18/11/2019	Valid
Clin Chem Cal 10345162338	Combined parameters in one product - class II	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	11/11/2019	Valid
Família Alinity c CK-MB 80146502230	Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	21/10/2019	Until 21/10/2029
Família Alinity c UIBC 80146502225	Iron-binding capacity (TIBC)	II	ABBOTT LABORATORIOS DO BRASIL LTDA	09/09/2019	Valid
Alinity c Lambda Light Chains Reagent Kit 80146502203	Kappa/lambda light chains	II	ABBOTT LABORATORIOS DO BRASIL LTDA	03/06/2019	Valid
Família Alinity c CRP 80146502187	C-reactive protein (CRP)	II	ABBOTT LABORATORIOS DO BRASIL LTDA	04/02/2019	Valid
Alinity c Creatinine (Enzymatic) Reagent Kit 80146502178	Creatinine	II	ABBOTT LABORATORIOS DO BRASIL LTDA	03/12/2018	Valid
Alinity c Iron Reagent kit 80146502163	Iron	II	ABBOTT LABORATORIOS DO BRASIL LTDA	03/09/2018	Valid
Alinity c Lithium Reagent Kit 80146502164	Lithium	III	ABBOTT LABORATORIOS DO BRASIL LTDA	03/09/2018	Until 13/04/2036
Alinity c Clinical Chemistry Calibrator Kit 80146502160	Combined parameters in one product - class III	III	ABBOTT LABORATORIOS DO BRASIL LTDA	20/08/2018	Until 30/03/2036
Família Alinity c Clinical Chemistry control kit 1 e control kit 2 80146502149	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	16/07/2018	Valid
Família Alinity c Immuno control 1 kit, immuno control 2 kit, immuno control set 80146502150	Combined parameters in one product - class III	III	ABBOTT LABORATORIOS DO BRASIL LTDA	16/07/2018	Until 27/07/2036
UIBC 80146502039	Iron-binding capacity (TIBC)	II	ABBOTT LABORATORIOS DO BRASIL LTDA	31/10/2017	Valid
Lipids Cal 10345162060	Combined parameters in one product - class II	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	17/10/2016	Valid
Lipids Control Set 10345162063	Combined parameters in one product - class II	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	17/10/2016	Valid
APO - Apolipoproteína B 10345162039	Apolipoprotein B	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	28/12/2015	Valid
APO - Apolipoproteína A-1 10345162040	Apolipoprotein A-I	II	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	28/12/2015	Valid
Fructosamine Controls 80146501917	Fructosamine	II	ABBOTT LABORATORIOS DO BRASIL LTDA	18/02/2015	Valid
IMMUNO CONTROLS 80146501909	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	12/01/2015	Valid
Clin Chem Cal 80146501809	Combined parameters in one product - class III	III	ABBOTT LABORATORIOS DO BRASIL LTDA	03/09/2012	Until 27/07/2036
Dibucaine CHE 80146501806	Dibucaine cholinesterase	II	ABBOTT LABORATORIOS DO BRASIL LTDA	23/07/2012	Valid
Bile Acids Controls 80146501789	Bile acids	II	ABBOTT LABORATORIOS DO BRASIL LTDA	09/07/2012	Valid

SENTINEL CH. SPA

Brazilian registration holders

Device types

Registrations (page 1 of 2, newest first)