SGTi-flex Dengue IgM/IgG

Dengue · class III · Until 01/09/2035

Registration no.: 10350840485
Process no.: 25351013260202552
Status: Until 01/09/2035
Device type: Dengue (DENGUE)
Risk class: III
Registration holder: BIOSYS LTDA CNPJ 02.220.795/0001-79 · 506 registrations
Manufacturer: SUGENTECH INC · South Korea
Published: 01/09/2025
Valid until: 01/09/2035
Last updated by ANVISA: 2026-10-12
Official record: View on ANVISA ↗

Other dengue registrations (194 in total, see all)

Product	Class	Holder	Published	Status
Teste Rápido Combinado Dengue NS1 IgG/IgM 10230730222	III	NL COMÉRCIO EXTERIOR LTDA	14/09/2026	Until 14/09/2036
Teste Rápido Dengue IgG/IgM 10230730223	III	NL COMÉRCIO EXTERIOR LTDA	14/09/2026	Until 14/09/2036
AFIAS Dengue NS1 Ag 10350840501	III	BIOSYS LTDA	08/09/2026	Until 08/09/2036
ULTRA Dengue Ag 80074330071	III	GLOBO REAGENTES E EQUIPAMENTOS P/ LABORATORIOS LTDA	31/08/2026	Until 31/08/2036
Anti-Dengue IgG Reagent Kit 10009010512	III	LABTEST DIAGNOSTICA S/A	24/08/2026	Until 24/08/2036
Família Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) 82444370454	III	Enzytec Biotecnologia Ltda.	24/08/2026	Until 24/08/2036
Família Dengue NS1+lgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) 82444370455	III	Enzytec Biotecnologia Ltda.	24/08/2026	Until 24/08/2036
Teste Rápido Combinado para Dengue em Cassete (Sangue Total/Soro/Plasma) 81325990500	III	QR CONSULTING, IMPORTACAO E DISTRIBUICAO DE PRODUTOS MEDICOS LTDA	20/07/2026	Until 20/07/2036