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ALTONA DIAGNOSTICS BRASIL LTDA

Brazilian registration holder · CNPJ 27.669.130/0001-78

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33registrations
31currently valid
2manufacturers
24device types
2020first registration
4class I
8class II
13class III
8class IV

Manufacturers represented

  • · Germany↗ 30
  • · Switzerland↗ 1

Device types

  • ↗ 3
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 1
  • ↗ 1
  • ↗ 1
  • ↗ 1
  • ↗ 1
  • ↗ 1
  • ↗ 1
  • ↗ 1
  • ↗ 1

Countries of manufacture

  • ↗ 30
  • ↗ 1

New registrations per year

  • 20206
  • 20211
  • 20222
  • 202320
  • 20241
  • 20263

Registrations

ProductDevice typeClass ManufacturerPublishedStatus
AltoStar Respiratory Sample Pretreatment Buffer 1.5
81752180033
 Buffers, diluents and other solutions for laboratory analysis I ALTONA DIAGNOSTICS GMBH 17/08/2026 Valid
AltoStar Pneumocystis jirovecii PCR Kit 1.5
81752180032
 Pneumocystis II ALTONA DIAGNOSTICS GMBH 15/06/2026 Valid
AltoStar HDV RT-PCR kit 1.5
81752180031
 Hepatitis D virus (HDV) III ALTONA DIAGNOSTICS GMBH 26/01/2026 Until 26/01/2036
AltoStar alpha Herpesvirus PCR Kit 1.5
81752180030
 Combined parameters in one product - class III III ALTONA DIAGNOSTICS GMBH 06/05/2024 Until 06/05/2034
AltoStar® HSV PCR Kit 1.5
81752180029
 Combined parameters in one product - class III III ALTONA DIAGNOSTICS GMBH 11/12/2023 Until 11/12/2033
AltoStar ® Whole Blood Pretreatment Buffer 1.5
81752180028
 Buffers, diluents and other solutions for laboratory analysis I ALTONA DIAGNOSTICS GMBH 27/11/2023 Valid
AltoStar® VZV PCR Kit 1.5
81752180027
 Herpesvirus (HHV-3) - varicella-zoster III ALTONA DIAGNOSTICS GMBH 23/10/2023 Until 23/10/2033
AltoStar® JCV PCR Kit 1.5
81752180026
 BK polyomavirus II ALTONA DIAGNOSTICS GMBH 07/08/2023 Valid
RealStar® Dengue RT-PCR Kit 2.0
81752180025
 Dengue III ALTONA DIAGNOSTICS GMBH 10/07/2023 Until 22/10/2028
AltoStar® HCV RT-PCR Kit 1.5
81752180024
 Hepatitis C virus (HCV) nucleic acid IV ALTONA DIAGNOSTICS GMBH 10/07/2023 Until 21/03/2032
RealStar® Malaria Screen & Type PCR Kit 1.0
81752180023
 Plasmodium nucleic acid (multiple species) IV ALTONA DIAGNOSTICS GMBH 10/07/2023 Until 20/12/2031
RealStar® HEV RT-PCR Kit 2.0
81752180022
 Hepatitis E virus (HEV) III ALTONA DIAGNOSTICS GMBH 10/07/2023 Until 04/11/2029
RealStar® SARS-CoV-2 RT-PCR Kit 1.0
81752180021
 Coronavirus III ALTONA DIAGNOSTICS GMBH 10/07/2023 Until 14/05/2030
AltoStar® HBV PCR Kit 1.5
81752180020
 Hepatitis B virus (HBV) core nucleic acid IV ALTONA DIAGNOSTICS GMBH 10/07/2023 Until 10/01/2032
AltoStar® HAV RT-PCR Kit 1.5
81752180019
 Hepatitis A virus (HAV) III ALTONA DIAGNOSTICS GMBH 10/07/2023 Until 05/12/2032
AltoStar® HEV RT-PCR Kit 1.5
81752180018
 Hepatitis E virus (HEV) III ALTONA DIAGNOSTICS GMBH 10/07/2023 Until 05/12/2032
AltoStar® HIV RT-PCR Kit 1.5
81752180017
 HIV-1 nucleic acid IV ALTONA DIAGNOSTICS GMBH 10/07/2023 Until 10/01/2032
RealStar® Zika Vírus RT-PCR Kit 1.0
81752180016
 Zika virus nucleic acid IV ALTONA DIAGNOSTICS GMBH 10/07/2023 Until 25/06/2028
REALSTAR®MALARIA PCR KIT 1.0.
81752180015
 Plasmodium nucleic acid (multiple species) IV ALTONA DIAGNOSTICS GMBH 10/07/2023 Until 17/09/2028
RealStar®Yellow Fever Virus RT-PCR Kit 1.0
81752180014
 Yellow fever III ALTONA DIAGNOSTICS GMBH 10/07/2023 Until 15/07/2029
RealStar® Chikungunya RT-PCR Kit 2.0
81752180013
 Chikungunya III ALTONA DIAGNOSTICS GMBH 10/07/2023 Until 10/06/2029
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (AS0821543)
81752180012
 Coronavirus III ALTONA DIAGNOSTICS GMBH 27/03/2023 Until 27/03/2033
AltoStar® CMV PCR Kit 1.5 (AS0021543)
81752180011
 Cytomegalovirus (CMV) nucleic acid IV ALTONA DIAGNOSTICS GMBH 20/03/2023 Until 20/03/2033
AltoStar® Parvovirus B19 PCR Kit 1.5 (AS0101543)
81752180010
 Parvovirus B19 III ALTONA DIAGNOSTICS GMBH 20/03/2023 Until 20/03/2033
AltoStar® Purification Kit 1.5 (PK15-46)
81752180009
 Buffers, diluents and other solutions for laboratory analysis I ALTONA DIAGNOSTICS GMBH 09/06/2022 Valid
AltoStar® Internal Control 1.5 (IC15-46)
81752180008
 Combined parameters in one product - class II II ALTONA DIAGNOSTICS GMBH 09/06/2022 Valid
AltoStar® BKV PCR Kit 1.5
81752180007
 BK polyomavirus II ALTONA DIAGNOSTICS GMBH 25/03/2021 Valid
AltoStar® Automation System AM16
81752180006
 Nucleic acid analyzer II HAMILTON BONADUZ AG 23/12/2020 Valid
AltoStar® Adenovirus PCR Kit 1.5
81752180005
 Adenovirus II ALTONA DIAGNOSTICS GMBH 08/09/2020 Valid
AltoStar® Internal Control 1.5
81752180004
 Not yet published II Not yet published 08/09/2020 Cancelled 30/10/2023
AltoStar® EBV PCR Kit 1.5
81752180003
 Epstein-Barr virus (EBV) nucleic acid IV ALTONA DIAGNOSTICS GMBH 08/09/2020 Until 30/03/2036
AltoStar® HHV-6 PCR Kit 1.5
81752180002
 Herpesvirus (HHV-6 or 7) II ALTONA DIAGNOSTICS GMBH 08/09/2020 Valid
AltoStar® Purification Kit 1.5
81752180001
 Not yet published I Not yet published 23/07/2020 Cancelled 30/10/2023