FaStep Covid-19 Ag II Assure Autoteste

Registration no.: 80885650065
Process no.: 25351223921202211
Status: Until 22/08/2032
Device type: Self-test for SARS-CoV-2 (coronavirus) antigen (AUTOTESTE PARA ANTÍGENO DO SARS-COV-2 (CORONAVÍRUS))
Risk class: III
Registration holder: ORBITAE DIAGNOSTICOS S/A CNPJ 11.162.384/0001-65 · 111 registrations
Manufacturer: ASSURE TECH. (HANGZHOU) CO., LTD. · China
Published: 22/08/2022
Valid until: 22/08/2032
Last updated by ANVISA: 2026-10-12
Official record: View on ANVISA ↗

Other self-test for sars-cov-2 (coronavirus) antigen registrations (67 in total, see all)

Product	Class	Holder	Published	Status
Prati-Donaduzzi Diagnósticos Teste Rápido do Antígeno do SARS-CoV-2 (COVID-19) (Nasal) 83056470005	III	PRATI DONADUZZI & CIA LTDA	05/01/2026	Until 05/01/2036
Autoteste Rápido de Antígeno de COVID-19 (SARS-CoV-2) 82444370299	III	Enzytec Biotecnologia Ltda.	24/10/2025	Until 24/10/2035
Autoteste Rápido para Covid-19 (Antígeno) 82444370274	III	Enzytec Biotecnologia Ltda.	29/09/2025	Until 29/09/2035
VivaDiag Pro SARS-CoV-2 Ag Rapid Test - AUTOTESTE 82286660013	III	SIGNAZ PRODUTOS E NEGOCIOS LTDA	01/09/2025	Until 01/09/2035
COVID-19 (SARS-CoV-2) Antigen Self-Test Kit 82444370196	III	Enzytec Biotecnologia Ltda.	17/02/2025	Until 17/02/2035
DETECTA COVID PLUS 80105220235	III	KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA	02/12/2024	Until 02/12/2034
SARS-CoV-2 Ag Autoteste 82533950100	III	MR SAUDE LTDA	18/11/2024	Until 18/11/2034
EVERCARE Autoteste COVID-19 Antígeno Nasal 10310030234	III	WAMA PRODUTOS PARA LABORATORIO LTDA	25/03/2024	Until 25/03/2034