SEEGENE DO BRASIL COMERCIO DE PRODUTOS MEDICOS E HOSPITALARES LTDA. (CNPJ 27.870.531/0001-91): 24 ANVISA registrations

Product	Device type	Class	Manufacturer	Published	Status
Allplex PneumoBacter Assay 81597710024	Combined parameters - respiratory panel	III	SEEGENE INC.	31/08/2026	Until 31/08/2036
Allplex SARS-CoV-2/FluA/FluB/RSV Assay 81597710023	Combined parameters - respiratory panel	III	SEEGENE INC.	24/08/2026	Until 24/08/2036
Allplex HPV28 Detection 81597710022	Human papillomavirus (HPV)	III	SEEGENE INC.	03/08/2026	Until 03/08/2036
Allplex STI Essential Assay 81597710021	Combined parameters in one product - class IV	IV	SEEGENE INC.	29/06/2026	Until 29/06/2036
Allplex Respiratory Panel 1A 81597710020	Combined parameters in one product - class III	III	SEEGENE INC.	13/04/2026	Until 13/04/2036
Seegene STARlet 81597710019	Sample preparation and processing instrument - pre-analytical phase	I	SEEGENE INC.	13/04/2026	Valid
AIOS 81597710018	Sample preparation and processing instrument - pre-analytical phase	I	SEEGENE INC.	13/04/2026	Valid
STARMag 96 X 4 Universal Cartridge Kit 81597710017	Buffers, diluents and other solutions for laboratory analysis	I	SEEGENE INC.	13/04/2026	Valid
Allplex RV Master Assay 81597710016	Combined parameters in one product - class III	III	SEEGENE INC.	08/12/2025	Until 08/12/2035
STARMag 96 X 4 Universal plus Cartridge Kit 81597710015	Buffers, diluents and other solutions for laboratory analysis	I	SEEGENE INC.	11/08/2025	Valid
UniVerse 81597710014	Sample preparation and processing instrument - pre-analytical phase	I	COPAN WASP SRL	07/04/2025	Valid
Kit de Extração de Ácido Nucleico Viral MagCore® (Alta Sensibilidade) 81597710013	Buffers, diluents and other solutions for laboratory analysis	I	RBC BIOSCIENCE CORP.	02/10/2023	Valid
Kit de DNA Genômico de Sangue Total MagCore® (Para Genotipagem) 81597710012	Buffers, diluents and other solutions for laboratory analysis	I	RBC BIOSCIENCE CORP.	02/10/2023	Valid
Kit de DNA Genômico de Sangue Total MagCore® (Instalação Rápida) 81597710011	Buffers, diluents and other solutions for laboratory analysis	I	RBC BIOSCIENCE CORP.	02/10/2023	Valid
Kit RNA triXact MagCore® 81597710010	Buffers, diluents and other solutions for laboratory analysis	I	RBC BIOSCIENCE CORP.	25/09/2023	Valid
Kit de DNA Genômico de Sangue Total MagCore® 81597710009	Buffers, diluents and other solutions for laboratory analysis	I	RBC BIOSCIENCE CORP.	25/09/2023	Valid
Kits de Extração de Ácidos Nucleicos TANBead W61E 81597710008	Buffers, diluents and other solutions for laboratory analysis	I	TAIWAN ADVANCED NANOTECH INC.	01/09/2022	Valid
Kits de Extração de Ácidos Nucleicos TANBead W61C 81597710007	Buffers, diluents and other solutions for laboratory analysis	I	TAIWAN ADVANCED NANOTECH INC.	01/09/2022	Valid
Kits de Extração de Ácidos nucleicos TANBead W621 81597710006	Buffers, diluents and other solutions for laboratory analysis	I	TAIWAN ADVANCED NANOTECH INC.	01/09/2022	Valid
Família Kits de Extração de Ácidos nucleicos TANBead W665 81597710005	Buffers, diluents and other solutions for laboratory analysis	I	TAIWAN ADVANCED NANOTECH INC. (TANBEAD)	01/09/2022	Valid
SARS-CoV-2 Spike-ACE2 Binding Assay Kit 81597710004	Not yet published	III	Not yet published	20/09/2021	Cancelled 28/04/2025
COVID-19 Ag Detection Kit (Colloidal Gold Immunochromaography) 81597710003	Not yet published	III	Not yet published	16/08/2021	Cancelled 28/04/2025
STARMag 96x4 Viral DNA/RNA 200 C Kit 81597710002	Buffers, diluents and other solutions for laboratory analysis	I	SEEGENE, INC.	22/10/2020	Valid
SARS-CoV-2 IgM/IgG Detection Kit (Colloidal Gold-Based) 81597710001	Not yet published	III	Not yet published	08/09/2020	Cancelled 28/04/2025

SEEGENE DO BRASIL COMERCIO DE PRODUTOS MEDICOS E HOSPITALARES LTDA.

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