USA DIAGNOSTICA LTDA

Brazilian registration holder · CNPJ 02.330.159/0001-08

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

106registrations
63currently valid
2manufacturers
37device types
2006first registration
5class I
54class II
26class III
21old classification

Manufacturers represented

  • · United States↗ 61
  • · Canada↗ 2

Device types

  • ↗ 4
  • ↗ 3
  • ↗ 3
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2

Countries of manufacture

  • ↗ 61
  • ↗ 2

New registrations per year

  • 200619
  • 200712
  • 20083
  • 20098
  • 201012
  • 20115
  • 201221
  • 201416
  • 20154
  • 20171
  • 20243
  • 20251
  • 20261

Registrations (page 1 of 3, highest registration number first)

ProductDevice typeClass ManufacturerPublishedStatus
PSA Total Test System - ELISA
80048490106
Prostate-specific antigen (PSA) III MONOBIND, INC 05/01/2026 Until 05/01/2036
17 alfa-OH Progesterona Test System – ELISA
80048490105
17-Hydroxyprogesterone (17-OHP) - newborn screening III MONOBIND, INC 12/05/2025 Until 12/05/2035
Folato Test System – ELISA
80048490104
Folate II MONOBIND, INC 23/12/2024 Valid
Estrona (E1) Test System – ELISA
80048490103
Estrone II MONOBIND, INC 23/12/2024 Valid
DHEA Test System – ELISA
80048490102
Dehydroepiandrosterone (DHEA) II MONOBIND, INC 23/12/2024 Valid
25-OH Vitamin D Total (Vit D-Direct) Test System – ELISA
80048490101
Vitamin D II MONOBIND INC. 11/12/2017 Valid
Ultra Sensitive Total Prostate Specific Antigen (PSA XS) Test System - CLIA
80048490100
Not yet published III Not yet published 20/07/2015 Expired 20/07/2025
Dehydroepiandrosterone (DHEA) Test System- CLIA
80048490099
Dehydroepiandrosterone (DHEA) II MONOBIND, INC 11/05/2015 Valid
Multi Ligand Control – Tri Level
80048490098
Combined parameters in one product - class III III MONOBIND, INC 11/05/2015 Until 11/05/2035
17 alfa-OH Progesterone Test System - ELISA
80048490097
Not yet published III Not yet published 05/01/2015 Expired 05/01/2025
Total Thyroxine (tT4) Test System - ELISA
80048490096
Thyroxine (T4) II MONOBIND, INC 22/09/2014 Valid
Ultra Sensitive Total Prostate Specific Antigen (PSA XS) Test System - ELISA
80048490095
Prostate-specific antigen (PSA) III MONOBIND, INC 15/09/2014 Until 15/09/2034
Família QSure H. Pylori Control
80048490094
Helicobacter pylori II MONOBIND, INC 15/09/2014 Valid
Vitamin B-12 (Vit B12) Test System - CLIA
80048490093
Vitamin B12 II MONOBIND, INC 15/09/2014 Valid
Neonatal TSH Test System – ELISA
80048490092
Not yet published III Not yet published 04/08/2014 Expired 04/08/2024
Neonatal Thyroxine Binding Globulin (N-TBG) Test System - ELISA
80048490091
Not yet published III Not yet published 28/07/2014 Expired 28/07/2024
Neonatal 17 alfa-OH Progesterone Test System – ELISA
80048490090
Not yet published III Not yet published 28/07/2014 Expired 28/07/2024
Neonatal T4 (Thyroxine) Test System - ELISA
80048490089
Not yet published III Not yet published 28/07/2014 Expired 28/07/2024
Estradiol (E2) Test System - ELISA
80048490088
Estradiol II MONOBIND, INC 28/07/2014 Valid
Free Testosterone Test System- ELISA
80048490087
Free testosterone II MONOBIND, INC 28/07/2014 Valid
Vitamin B-12 (Vit B12) Test System - ELISA
80048490086
Vitamin B12 II MONOBIND, INC 28/07/2014 Valid
Progesterone Test System - ELISA
80048490085
Progesterone II MONOBIND, INC 28/07/2014 Valid
Anti-H. Pylori IgA Test System- ELISA
80048490084
Helicobacter pylori II MONOBIND, INC 14/04/2014 Valid
Growth Hormone (hGH) Test System- ELISA
80048490083
Human growth hormone (hGH, GH or somatotropin) II MONOBIND, INC 14/04/2014 Valid
Cortisol Test System- ELISA
80048490082
Cortisol/cortisone II MONOBIND, INC 14/04/2014 Valid
Testosterone Test System - ELISA
80048490081
Testosterone II MONOBIND, INC 31/03/2014 Valid
FOLLICLE STIMULATING HORMONE (FSH)
80048490080
Follicle-stimulating hormone (FSH) II MONOBIND INC. 27/02/2012 Valid
FERRITIN
80048490079
Ferritin II MONOBIND INC. 27/02/2012 Valid
ANTI-THYROID PEROXIDASE (ANTI-TPO)
80048490078
Antithyroid antibody (anti-TPO) II MONOBIND INC. 27/02/2012 Valid
TRIIODOTHYRONINE (T3)
80048490077
Triiodothyronine (T3) II MONOBIND INC. 27/02/2012 Valid
TOTAL THYROXINE (tT4)
80048490076
Thyroxine (T4) II MONOBIND INC. 27/02/2012 Valid
FREE THYROXINE (fT4)
80048490075
Free thyroxine (FT4) II MONOBIND INC. 27/02/2012 Valid
THYROTROPIN (TSH)
80048490074
Thyroid-stimulating hormone (TSH) II MONOBIND INC 27/02/2012 Valid
LUTEINIZING HORMONE (LH)
80048490073
Luteinizing hormone (LH) II MONOBIND INC. 27/02/2012 Valid
CK-MB
80048490072
Not yet published III Not yet published 27/02/2012 Expired 27/02/2017
THYROGLOBULIN (TG)
80048490071
Thyroglobulin (Tg) II MONOBIND INC. 27/02/2012 Valid
ANTI-THYROGLOBULIN (ANTI-TG)
80048490070
Antithyroid antibody (anti-TPO) II MONOBIND INC. 27/02/2012 Valid
FREE TRIIODOTHYRONINE (fT3)
80048490069
Free triiodothyronine (FT3) II MONOBIND INC. 27/02/2012 Valid
CA-125 TEST SYSTEM
80048490068
CA 125 antigen III MONOBIND, INC 06/02/2012 Until 06/02/2027
Myoglobin TEST SYSTEM
80048490067
Not yet published II Not yet published 06/02/2012 Cancelled 09/06/2025
IgE TEST SYSTEM
80048490066
Immunoglobulin E II MONOBIND, INC 06/02/2012 Valid
CA 19-9 TEST SYSTEM
80048490065
CA 19-9 antigen III MONOBIND, INC 06/02/2012 Until 06/02/2027
TROPONINA-I (cTnI) TEST SYSTEM
80048490064
Not yet published III Not yet published 06/02/2012 Expired 06/02/2017
AFP TEST SYSTEM
80048490063
Not yet published III Not yet published 06/02/2012 Expired 06/02/2017
CA 15-3 TEST SYSTEM
80048490062
CA 15-3 antigen III MONOBIND, INC 06/02/2012 Until 06/02/2027
CK-MB (CREATINE KINASE) TEST SYSTEM
80048490061
Creatine kinase (CK) II MONOBIND INC 06/02/2012 Valid
CEA TEST SYSTEM
80048490060
Carcinoembryonic antigen (CEA) III MONOBIND, INC 06/02/2012 Until 06/02/2027
DIRECT TOTAL TESTOSTERONE ELISA KIT
80048490059
Testosterone II DIAGNOSTICS BIOCHEM CANADA INC 31/10/2011 Valid
DIRECT FREE TESTOSTERONE ELISA KIT
80048490058
Free testosterone II DIAGNOSTICS BIOCHEM CANADA INC 31/10/2011 Valid
INSULIN TEST SYSTEM
80048490057
Insulin II MONOBIND, INC 15/08/2011 Valid