Cobas HEV

Hepatitis E virus (HEV) · class III · Until 10/08/2035

Registration no.: 10287411103
Process no.: 25351334311201514
Status: Until 10/08/2035
Device type: Hepatitis E virus (HEV) (VÍRUS DE HEPATITE E (HEV))
Risk class: III
Registration holder: ROCHE DIAGNÓSTICA BRASIL LTDA CNPJ 30.280.358/0001-86 · 1,784 registrations
Manufacturer: ROCHE MOLECULAR SYSTEMS, INC · United States
Published: 10/08/2015
Valid until: 10/08/2035
Last updated by ANVISA: 2026-10-12
Official record: View on ANVISA ↗

Other hepatitis e virus (hev) registrations (18 in total, see all)

Product	Class	Holder	Published	Status
Micropartículas HEV IgM (CLIA) 80102513389	III	VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA	17/03/2025	Until 17/03/2035
Micropartículas HEV IgG (CLIA) 80102513386	III	VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA	10/03/2025	Until 10/03/2035
Família Anti-HEV IgG 10287411706	III	ROCHE DIAGNÓSTICA BRASIL LTDA	25/11/2024	Until 25/11/2034
Família Anti-HEV IgM 10287411703	III	ROCHE DIAGNÓSTICA BRASIL LTDA	30/09/2024	Until 30/09/2034
HEPATITIS E VIRCLIA® IgG MONOTEST 81816720064	III	ALIFAX BRASIL COMER., EXP., IMP., DIST. DE EQUIPAMENTOS E REAGENTES PARA DIAGNOSTICO IN VITRO LTDA	08/07/2024	Until 08/07/2034
HEPATITIS E VIRCLIA® IgM MONOTEST 81816720065	III	ALIFAX BRASIL COMER., EXP., IMP., DIST. DE EQUIPAMENTOS E REAGENTES PARA DIAGNOSTICO IN VITRO LTDA	08/07/2024	Until 08/07/2034
AltoStar® HEV RT-PCR Kit 1.5 81752180018	III	ALTONA DIAGNOSTICS BRASIL LTDA	10/07/2023	Until 05/12/2032
RealStar® HEV RT-PCR Kit 2.0 81752180022	III	ALTONA DIAGNOSTICS BRASIL LTDA	10/07/2023	Until 04/11/2029