BECTON DICKINSON AND COMPANY (SPARKS): Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
Família BD Phoenix 10033430921	Culture media and devices for antimicrobial susceptibility testing	II	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	05/10/2026	Valid
Família BD BACTEC™ MGIT™ II 10033430920	Microorganism identification or susceptibility testing instrument	II	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	24/08/2026	Valid
FAMÍLIA BD BACTEC™ FXI 10033430919	Microorganism identification or susceptibility testing instrument	II	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	06/07/2026	Valid
BDXpert™ System 10033430917	IVD software	II	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	08/06/2026	Valid
BD PhoenixSpec™ AP Calibrator Kit 10033430904	Solution for performance testing of equipment components	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	22/04/2026	Valid
BD Phoenix™ AP ID Broth 10033430905	Buffers, diluents and other solutions for laboratory analysis	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	22/04/2026	Valid
BD MAX ExK DNA-2 10033430892	Buffers, diluents and other solutions for laboratory analysis	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	16/06/2025	Valid
BD MAX ExK DNA-3 10033430893	Buffers, diluents and other solutions for laboratory analysis	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	16/06/2025	Valid
BD MAX ExK DNA-1 10033430888	Buffers, diluents and other solutions for laboratory analysis	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	07/04/2025	Valid
BD Respiratory Viral Panel for BD MAX System IVD 10033430886	Combined parameters in one product - class III	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	24/02/2025	Until 24/02/2035
BD Molecular LBC Sample Buffer Tubes 10033430880	Container or material for collection, storage or transport of biological samples	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	23/12/2024	Valid
BD Veritor System For Rapid Detection of SARS-CoV-2 e Flu A+B 10033430873	Combined parameters - respiratory panel	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	28/08/2023	Until 28/08/2033
BD BACTEC™ MycoF Lytic Culture Vials 10033430870	Selective culture media for specific groups of microorganisms	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	24/07/2023	Valid
BD MAX CPO 10033430857	Carbapenemase-producing microorganisms	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	28/11/2022	Until 12/01/2036
BD CTGCTV2 for BD MAX System 10033430852	Combined parameters in one product - class IV	IV	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	15/08/2022	Until 15/08/2032
BD Molecular Swab Collection Kit 10033430851	Container or material for collection, storage or transport of biological samples	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	14/07/2022	Valid
BD Onclarity HPV Self Collection Diluent Tubes 10033430843	Buffers, diluents and other solutions for laboratory analysis	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	04/11/2021	Valid
BD Veritor System for Rapid Detection of Group A Strep 10033430840	Streptococcus	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	25/10/2021	Until 25/10/2031
BD Veritor System for Rapid Detection of Flu A and B Clia Waived 10033430841	Influenza A and B viruses	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	25/10/2021	Until 25/10/2031
BD BACTEC Platelet Anaerobic/F Culture Vials 10033430836	Culture media and devices for anaerobe testing	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	30/09/2021	Valid
BD BACTEC Platelet Aerobic/F Culture Vials 10033430834	Culture media and devices for primary inoculation only	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	02/09/2021	Valid
BD MAX Extended Enteric Bacterial Panel 10033430819	Combined parameters in one product - class III	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	21/09/2020	Until 21/09/2030
BD MAX Vaginal Panel 10033430816	Combined parameters in one product - class III	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	31/08/2020	Until 31/08/2030
BD MAX Enteric Viral Panel 10033430817	Combined parameters in one product - class III	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	31/08/2020	Until 31/08/2030
BD Veritor System for Rapid Detection of RSV Clia Waived 10033430813	Respiratory syncytial virus (RSV)	II	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	29/06/2020	Valid
BD Max Enteric Parasite Panel 10033430781	Combined parameters in one product - class II	II	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	23/12/2019	Valid
Família BD Phoenix Painéis Gram Negativos 10033430775	Culture media and devices for antimicrobial susceptibility testing	II	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	22/04/2019	Valid
Control Set for the BD ProbeTec Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Qx Amplified DNA Assays 10033430772	Combined parameters in one product - class IV	IV	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	15/04/2019	Until 15/04/2029
BD Control Set for the BD Onclarity HPV Assay 10033430716	Human papillomavirus (HPV)	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	21/12/2015	Until 21/12/2035
BD Onclarity HPV Assay 10033430713	Human papillomavirus (HPV)	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	03/11/2015	Until 03/11/2035
BD FOX PCR Extraction Tubes 10033430712	Buffers, diluents and other solutions for laboratory analysis	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	26/10/2015	Valid
BD MAX StaphSR 10033430710	Staphylococcus spp.	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	20/10/2015	Until 20/10/2035
BD Onclarity Tubos de Diluente para Citologia em Base Líquida (LBC) para HPV 10033430704	Buffers, diluents and other solutions for laboratory analysis	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	08/09/2015	Valid
BD MAX Enteric Bacterial Panel 10033430702	Combined parameters in one product - class III	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	08/06/2015	Until 25/08/2035
BD MAX CDIFF IVD 10033430678	Clostridium difficile (Clostridioides difficile)	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	24/02/2014	Until 01/09/2035
BD Phoenix Gram Positivo 10033430635	Differential culture media and devices for biochemical identification of microorganisms	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	26/12/2011	Valid
Família BD BACTEC MGIT 960 Sensibilidade 10033430440	Mycobacterium	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	24/10/2005	Until 01/09/2035
BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes 10033430437	Mycobacterium	III	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	17/10/2005	Until 17/10/2035
BD BBL™ MGIT™ OADC ENRICHMENT 10033430428	Culture media and devices for enrichment	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	19/09/2005	Valid
BD PHOENIX AST BROTH 10033430409	Culture media and devices for antimicrobial susceptibility testing	II	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	11/07/2005	Valid
BD BBL MycoPrep Kit 10033430123	Culture media and devices for enrichment	I	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	25/02/1997	Valid
EQUIPAMENTO AUTOMATIZADO PARA HEMOCULTURA BACTEC-F 10033430112	Blood culture system (microorganism growth detection)	II	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	25/06/1996	Valid

BECTON DICKINSON AND COMPANY (SPARKS)

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