ABBOTT MOLECULAR INC: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
simpli-Collect HPV Collection Kit 80146502414	Container or material for collection, storage or transport of biological samples	I	ABBOTT LABORATORIOS DO BRASIL LTDA	03/11/2025	Valid
Família Alinity m EBV WB 80146502410	Epstein-Barr virus (EBV) nucleic acid	IV	ABBOTT LABORATORIOS DO BRASIL LTDA	16/06/2025	Until 16/06/2035
Familia Alinity m EBV 80146502411	Epstein-Barr virus (EBV) nucleic acid	IV	ABBOTT LABORATORIOS DO BRASIL LTDA	16/06/2025	Until 16/06/2035
Família Alinity m HSV 1 & 2 / VZV 80146502405	Combined parameters in one product - class III	III	ABBOTT LABORATORIOS DO BRASIL LTDA	02/06/2025	Until 02/06/2035
Família Alinity m CMV WB 80146502403	Cytomegalovirus (CMV) nucleic acid	IV	ABBOTT LABORATORIOS DO BRASIL LTDA	26/05/2025	Until 26/05/2035
Família Alinity m Specimen Buffer 80146502400	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	28/04/2025	Valid
Família Alinity m BKV 80146502389	BK polyomavirus	II	ABBOTT LABORATORIOS DO BRASIL LTDA	22/04/2024	Valid
Alinity m Urine Transport Kit 80146502390	Container or material for collection, storage or transport of biological samples	I	ABBOTT LABORATORIOS DO BRASIL LTDA	22/04/2024	Valid
Alinity m Multi-Collect Specimen Collection Kit 80146502340	Container or material for collection, storage or transport of biological samples	I	ABBOTT LABORATORIOS DO BRASIL LTDA	30/09/2021	Valid
Alinity mp System 80146502342	Sample preparation and processing instrument - pre-analytical phase	I	ABBOTT LABORATORIOS DO BRASIL LTDA	30/09/2021	Valid
Alinity m CMV 80146502339	Cytomegalovirus (CMV) IgM	IV	ABBOTT LABORATORIOS DO BRASIL LTDA	20/09/2021	Until 20/09/2031
Família Alinity m SARS CoV-2 80146502332	Coronavirus	III	ABBOTT LABORATORIOS DO BRASIL LTDA	22/03/2021	Until 22/03/2031
Família Abbott RealTime SARS-CoV-2 80146502251	Coronavirus	III	ABBOTT LABORATORIOS DO BRASIL LTDA	11/05/2020	Until 11/05/2030
Família Alinity m HBV 80146502204	Viral load monitoring - hepatitis B virus (HBV)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	09/09/2019	Until 09/09/2029
Família Alinity m HIV-1 80146502221	HIV-1 nucleic acid	IV	ABBOTT LABORATORIOS DO BRASIL LTDA	02/09/2019	Until 02/09/2029
Família Alinity m HCV 80146502222	Hepatitis C virus (HCV) nucleic acid	IV	ABBOTT LABORATORIOS DO BRASIL LTDA	02/09/2019	Until 02/09/2029
Família Alinity m System 80146502220	Nucleic acid analyzer	II	ABBOTT LABORATORIOS DO BRASIL LTDA	05/08/2019	Valid
Alinity m Specimen Dilution Kit I 80146502214	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	27/06/2019	Valid
Alinity m Lysis Solution 80146502215	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	27/06/2019	Valid
Alinity m Ethanol Solution 80146502216	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	27/06/2019	Valid
Alinity m Vapor Barrier Solution 80146502217	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	27/06/2019	Valid
Alinity m Diluent Solution 80146502218	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	27/06/2019	Valid
Família Alinity m STI 80146502213	Combined parameters in one product - class III	III	ABBOTT LABORATORIOS DO BRASIL LTDA	17/06/2019	Until 17/06/2029
Alinity m Sample Prep Kit 2 80146502208	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	13/06/2019	Valid
Alinity m Sample Prep Kit 1 80146502209	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	13/06/2019	Valid
Alinity m Cervi-Collect Specimen Collection Kit 80146502210	Container or material for collection, storage or transport of biological samples	I	ABBOTT LABORATORIOS DO BRASIL LTDA	13/06/2019	Valid
Alinity m multi-Collect Specimen Collection Kit 80146502211	Container or material for collection, storage or transport of biological samples	I	ABBOTT LABORATORIOS DO BRASIL LTDA	13/06/2019	Valid
Família Alinity m Tubes 80146502207	Container or material for collection, storage or transport of biological samples	I	ABBOTT LABORATORIOS DO BRASIL LTDA	06/06/2019	Valid
Família Alinity m HR HPV 80146502206	Human papillomavirus (HPV)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	03/06/2019	Until 03/06/2029
Vysis EGR1 FISH Probe Kit, SC 80146502061	Probes for leukemia and lymphoma markers	III	ABBOTT LABORATORIOS DO BRASIL LTDA	04/12/2017	Until 04/12/2027
Família Abbott RealTime HIV-1 80146502046	Viral load monitoring - human immunodeficiency virus type 1 (HIV-1)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	27/11/2017	Until 27/11/2027
Família Abbott RealTime CMV 80146502016	Cytomegalovirus (CMV) nucleic acid	IV	ABBOTT LABORATORIOS DO BRASIL LTDA	11/09/2017	Until 11/09/2027
Vysis ALK 80146501983	Probes for respiratory system pathology and neoplasm markers	III	ABBOTT LABORATORIOS DO BRASIL LTDA	01/03/2017	Until 01/03/2037
Vysis CLL FISH Probe Kit (CE) 80146501979	Probes for leukemia and lymphoma markers	III	ABBOTT LABORATORIOS DO BRASIL LTDA	06/02/2017	Until 06/02/2037
Vysis CLL FISH Probe Kit (US) 80146501981	Probes for leukemia and lymphoma markers	III	ABBOTT LABORATORIOS DO BRASIL LTDA	06/02/2017	Until 06/02/2037
VP 2000 Pretreatment Kit 80146501977	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	23/01/2017	Valid
Abbott mSample Preparation System DBS Buffer Kit 80146501975	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	14/11/2016	Valid
Família ABBOTT RealTime EBV 80146501974	Epstein-Barr virus (EBV) nucleic acid	IV	ABBOTT LABORATORIOS DO BRASIL LTDA	17/10/2016	Until 18/05/2036
Optical Calibration Kit 80146501851	Solution for performance testing of equipment components	I	ABBOTT LABORATORIOS DO BRASIL LTDA	19/08/2013	Valid
Proteinase K 80146501833	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	24/06/2013	Valid
Uracil-N-Glycosylase, GPR 80146501829	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	08/04/2013	Valid
ABBOTT VP2000 PROCESSOR 80146509035	Sample preparation and processing instrument - pre-analytical phase	II	ABBOTT LABORATORIOS DO BRASIL LTDA	26/03/2012	Valid
Abbott Cervi-Collect Specimen Collection Kit 80146501768	Container or material for collection, storage or transport of biological samples	I	ABBOTT LABORATORIOS DO BRASIL LTDA	05/09/2011	Valid
Abbott RealTime HCV Genotype II Controls / Abbott RealTime HCV Genótipo II Controles 80146501755	Hepatitis C virus (HCV) nucleic acid	IV	ABBOTT LABORATORIOS DO BRASIL LTDA	25/04/2011	Until 25/04/2036
Abbott RealTime HCV Genotype II Amplification Reagent Kit / Abbott RealTime HCV Genótipo II Kit Reagente de Amplificação 80146501756	Hepatitis C virus (HCV) nucleic acid	IV	ABBOTT LABORATORIOS DO BRASIL LTDA	25/04/2011	Until 25/04/2036
Abbott Multi-Collect Specimen Collection Kit 80146501758	Container or material for collection, storage or transport of biological samples	I	ABBOTT LABORATORIOS DO BRASIL LTDA	25/04/2011	Valid
M2000SP 80146501740	Sample preparation and processing instrument - pre-analytical phase	I	ABBOTT LABORATORIOS DO BRASIL LTDA	21/03/2011	Valid
M24SP 80146509032	Sample preparation equipment for in vitro diagnostics	I	ABBOTT LABORATORIOS DO BRASIL LTDA	21/03/2011	Valid
Abbott RealTime CT/NG Controls / Abbott RealTime CT/NG Controles 80146501729	Combined parameters in one product - class IV	IV	ABBOTT LABORATORIOS DO BRASIL LTDA	22/02/2011	Until 22/02/2036
Abbott RealTime CT/NG Amplification Reagent Kit / Abbott RealTime CT/NG Kit Reagente de Amplificação 80146501731	Combined parameters in one product - class IV	IV	ABBOTT LABORATORIOS DO BRASIL LTDA	22/02/2011	Until 22/02/2036

ABBOTT MOLECULAR INC

Brazilian registration holders

Device types

Registrations (page 1 of 2, newest first)