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SETTY ASSESSORIA E CONSULTORIA EM ASSUNTOS REGULATORIOS LTDA

Brazilian registration holder · CNPJ 26.406.496/0001-91

Tick manufacturers, device types or countries below to filter this page.

24registrations
15currently valid
2manufacturers
13device types
2020first registration
9class II
10class III
5class IV

Manufacturers represented

  • · China↗ 12
  • · China↗ 3

Device types

  • ↗ 2
  • ↗ 2
  • ↗ 1
  • ↗ 1
  • ↗ 1
  • ↗ 1
  • ↗ 1
  • ↗ 1
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Countries of manufacture

New registrations per year

  • 20202
  • 202311
  • 20248
  • 20263

Registrations

ProductDevice typeClass ManufacturerPublishedStatus
COMBO TESTE AG ROTAVIRUS/ADENOVIRUS/NOROVIRUS (Fezes) INNOVITA
81552290024
 Combined parameters in one product - class II II INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD. 21/09/2026 Valid
COMBO TESTE AG RSV/ADV/hMPV/PIV (Swab nasofaríngeo) INNOVITA
81552290023
 Combined parameters in one product - class II II INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD. 21/09/2026 Valid
CASSETE DE TESTE RÁPIDO DE ANTÍGENO H.PYLORI (FEZES) INNOVITA
81552290022
 Helicobacter pylori II INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD. 21/09/2026 Valid
Teste FlashDetect™ LyocartD SARS-CoV-2&Flu A&Flu B
81552290021
 Not yet published III Not yet published 14/10/2024 Cancelled 28/01/2025
Família Teste FlashDetect™ LyocartD Strep A
81552290020
 Not yet published III Not yet published 09/09/2024 Cancelled 28/01/2025
Família Teste FlashDetect™ LyocartD CT&NG&UU
81552290019
 Not yet published III Not yet published 09/09/2024 Cancelled 28/01/2025
Família Teste FlashDetect™ LyocartD MG&TV&MH
81552290018
 Not yet published III Not yet published 09/09/2024 Cancelled 28/01/2025
Família Teste FlashDetect™ LyocartD HSV-1&HSV-2
81552290017
 Not yet published III Not yet published 09/09/2024 Cancelled 28/01/2025
FAMÍLIA TESTE RÁPIDO DE ANTICORPO DE SÍFILIS (Treponema Pallidum)
81552290016
 Treponema pallidum total antibodies IV QINGDAO HIGHTOP BIOTECH CO.,LTD. 15/04/2024 Until 15/04/2034
Família Teste Rápido de Anticorpo HIV 1/2
81552290015
 HIV-1/HIV-2 antibody IV QINGDAO HIGHTOP BIOTECH CO.,LTD. 15/04/2024 Until 15/04/2034
FAMÍLIA TESTE RÁPIDO DE ANTICORPO DO VÍRUS DA HEPATITE C PARA HCV
81552290014
 Total antibody to hepatitis C virus (anti-HCV) IV QINGDAO HIGHTOP BIOTECH CO.,LTD. 18/03/2024 Until 18/03/2034
Kit de Detecção DirectDetectTM SARS-CoV-2 (PCR – Sonda de Fluorescência)
81552290013
 Not yet published III Not yet published 27/11/2023 Cancelled 28/01/2025
Teste Rápido de Ovulação LH
81552290012
 Fertility self-test II QINGDAO HIGHTOP BIOTECH CO.,LTD. 27/11/2023 Valid
FAMÍLIA TESTE RÁPIDO PARA ANTÍGENO DE GONORRÉIA
81552290011
 Neisseria gonorrhoeae antigen IV QINGDAO HIGHTOP BIOTECH CO.,LTD. 02/10/2023 Until 02/10/2033
Família Teste Rápido de Anticorpos IgG para Tuberculose
81552290010
 Mycobacterium III QINGDAO HIGHTOP BIOTECH CO.,LTD. 25/09/2023 Until 25/09/2033
FAMÍLIA TESTE RÁPIDO PARA ANTÍGENO DE CHLAMYDIA TRACHOMATIS (Ct)
81552290009
 Chlamydia trachomatis antigen IV QINGDAO HIGHTOP BIOTECH CO.,LTD. 28/08/2023 Until 28/08/2033
Família FOB – TESTE RÁPIDO DE SANGUE OCULTO NAS FEZES
81552290008
 Fecal occult blood III QINGDAO HIGHTOP BIOTECH CO.,LTD. 28/08/2023 Until 28/08/2033
Teste Rápido de Rotavírus Ag
81552290007
 Rotavirus II QINGDAO HIGHTOP BIOTECH CO.,LTD. 29/05/2023 Valid
Teste Rápido de Adenovírus Ag
81552290006
 Adenovirus II QINGDAO HIGHTOP BIOTECH CO.,LTD. 29/05/2023 Valid
Teste Rápido de Anticorpos H Pylori
81552290005
 Helicobacter pylori II QINGDAO HIGHTOP BIOTECH CO.,LTD. 29/05/2023 Valid
Teste Rápido de Ovulação LH
81552290004
 Not yet published II Not yet published 29/05/2023 Cancelled 25/09/2023
Teste Rápido de Gravidez HCG
81552290003
 Self-test for human chorionic gonadotropin (hCG) II QINGDAO HIGHTOP BIOTECH CO.,LTD. 29/05/2023 Valid
Kit de Detecção Bosphore Novel Coronavírus (2019-nCoV) v2
81552290002
 Not yet published III Not yet published 06/08/2020 Expired 06/08/2021
SARS-CoV-2 Antibody Test (colloidal gold immunochromatography)
81552290001
 Not yet published III Not yet published 18/06/2020 Expired 18/06/2021