ROCHE DIAGNÓSTICA BRASIL LTDA

Brazilian registration holder · CNPJ 30.280.358/0001-86

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1,784registrations
997currently valid
35manufacturers
293device types
1996first registration
267class I
863class II
446class III
125class IV
83old classification

Registrations (page 5 of 36, highest registration number first)

ProductDevice typeClass ManufacturerPublishedStatus
Control Set DAT Clinical
10287411630
Not yet published II Not yet published 22/09/2022 Cancelled 09/06/2025
Preciset DAT Plus II
10287411629
Not yet published II Not yet published 22/09/2022 Cancelled 26/05/2025
Família Precimat Chromogen e PreciChrom I/II
10287411628
Antithrombin II ROCHE DIAGNOSTICS GMBH 22/09/2022 Valid
Elecsys AFP 09015060190
10287411627
Not yet published III Not yet published 19/09/2022 Cancelled 27/07/2026
Elecsys PIVKA-II
10287411626
Des-gamma-carboxy prothrombin (DCP) - protein induced by vitamin K absence or antagonist-II (PIVKA-II) III ROCHE DIAGNOSTICS GMBH 19/09/2022 Until 19/09/2032
Elecsys AFP 09015086190
10287411625
Not yet published III Not yet published 19/09/2022 Cancelled 27/07/2026
Família PIVKA-II
10287411624
Des-gamma-carboxy prothrombin (DCP) - protein induced by vitamin K absence or antagonist-II (PIVKA-II) III ROCHE DIAGNOSTICS GMBH 19/09/2022 Until 19/09/2032
Família Elecsys AFP
10287411623
Alpha-fetoprotein (AFP) III ROCHE DIAGNOSTICS GMBH 19/09/2022 Until 19/09/2032
Família Elecsys FT4 IV
10287411622
Free thyroxine (FT4) II ROCHE DIAGNOSTICS GMBH 15/09/2022 Valid
Elecsys PAPP-A 08860173190
10287411621
Pregnancy-associated plasma protein A (PAPP-A) III ROCHE DIAGNOSTICS GMBH 05/09/2022 Until 05/09/2032
Família Elecsys PAPP-A
10287411620
Pregnancy-associated plasma protein A (PAPP-A) III ROCHE DIAGNOSTICS GMBH 05/09/2022 Until 05/09/2032
Special Stains Van Gieson CS
10287411619
Cytological stains I VENTANA MEDICAL SYSTEM, INC 01/09/2022 Valid
Elastic Stain Core Kit
10287411618
Cytological stains I VENTANA MEDICAL SYSTEM, INC 01/09/2022 Valid
cobas omni Utility Channel Reagent Kit
10287411617
Buffers, diluents and other solutions for laboratory analysis I ROCHE MOLECULAR SYSTEMS, INC 01/09/2022 Valid
Família Elecsys HSV-2 IgG
10287411616
Herpes simplex virus (HHV-2) III ROCHE DIAGNOSTICS GMBH 30/08/2022 Until 30/08/2032
Família Elecsys HSV-1 IgG
10287411615
Herpes simplex virus (HHV-1) II ROCHE DIAGNOSTICS GMBH 30/08/2022 Valid
Elecsys Anti-HAV II 08086630190
10287411614
Hepatitis A virus (HAV) III ROCHE DIAGNOSTICS GMBH 08/08/2022 Until 08/08/2032
Família Elecsys Troponin T hs STAT
10287411613
Troponin III ROCHE DIAGNOSTICS GMBH 08/08/2022 Until 08/08/2032
Elecsys BRAHMS PCT
10287411612
Not yet published II Not yet published 14/07/2022 Cancelled 09/06/2025
Família Elecsys ACTH
10287411611
Adrenocorticotropic hormone (ACTH) II ROCHE DIAGNOSTICS GMBH 07/07/2022 Valid
Família Elecsys Anti-Tg
10287411610
Thyroglobulin (Tg) - tumor marker III ROCHE DIAGNOSTICS GMBH 07/07/2022 Until 01/09/2035
BenchMark Special Stains Cleaning Kit
10287411609
Not yet published I Not yet published 07/07/2022 Cancelled 31/03/2025
Elecsys Anti-Tg 09004998190
10287411608
Not yet published II Not yet published 07/07/2022 Cancelled 09/06/2025
Elecsys ACTH 08946710190
10287411607
Adrenocorticotropic hormone (ACTH) II ROCHE DIAGNOSTICS GMBH 07/07/2022 Valid
Família cobas Bulk Loader Input Module (BLIM)
10287411606
Sample preparation and processing instrument - pre-analytical phase I ROCHE DIAGNOSTICS GMBH 07/07/2022 Valid
Elecsys Androstenedione
10287411605
Androstenedione II ROCHE DIAGNOSTICS GMBH 07/07/2022 Valid
Elecsys Tg II 08906556190
10287411604
Not yet published II Not yet published 07/07/2022 Cancelled 09/06/2025
Elecsys AMH Plus 08818916190
10287411603
Not yet published II Not yet published 07/07/2022 Cancelled 02/02/2026
Elecsys S100_08817324190
10287411602
S100 protein III ROCHE DIAGNOSTICS GMBH 20/06/2022 Until 20/06/2032
SARS-CoV-2 Antigen Self Test Nasal
10287411601
Self-test for SARS-CoV-2 (coronavirus) antigen III SD BIOSENSOR 13/06/2022 Until 13/06/2032
Precinorm U plus
10287411600
Combined parameters in one product - class III III ROCHE DIAGNOSTICS GMBH 06/06/2022 Until 06/06/2032
MagNA Pure 24 MGP Set
10287411599
Buffers, diluents and other solutions for laboratory analysis I ROCHE MOLECULAR SYSTEMS, INC 11/03/2022 Valid
MagNA Pure 24 Total NA Isolation Kit
10287411598
Buffers, diluents and other solutions for laboratory analysis I ROCHE MOLECULAR SYSTEMS, INC. 11/03/2022 Valid
Cobas® 5800 System
10287411597
Nucleic acid analyzer II ROCHE MOLECULAR SYSTEMS, INC 03/03/2022 Valid
Família cobas® SARS-CoV-2
10287411596
Coronavirus III ROCHE MOLECULAR SYSTEMS, INC 02/03/2022 Until 02/03/2032
NAVIFY THERAPY MATCHER
10287411595
Not yet published II Not yet published 17/02/2022 Cancelled 12/09/2022
Família cobas® SARS-CoV-2 & Influenza A/B
10287411594
Combined parameters - respiratory panel III ROCHE MOLECULAR SYSTEMS, INC 07/02/2022 Until 07/02/2032
Família KIT LIAT Cobas SARS-CoV-2 & Influenza AB
10287411593
Combined parameters - respiratory panel III ROCHE MOLECULAR SYSTEMS, INC 31/01/2022 Until 31/01/2032
Elecsys BRAHMS PCT
10287411592
Not yet published II Not yet published 20/01/2022 Cancelled 12/05/2025
PreciControl ClinChem Multi
10287411591
Not yet published II Not yet published 20/01/2022 Cancelled 12/05/2025
Cobas Pure c 303
10287411590
Analyzer for general chemistry, hormones, drugs or proteins II ROCHE DIAGNOSTICS GMBH 02/12/2021 Valid
Cobas Pure e 402
10287411589
Immunoassay instrument II ROCHE DIAGNOSTICS GMBH 02/12/2021 Valid
Família Elecsys HBsAg II Auto Confirm
10287411588
Hepatitis B surface antigen (HBsAg) IV ROCHE DIAGNOSTICS GMBH 06/12/2021 Until 06/12/2031
Família Elecsys Vitamin D total III
10287411587
Vitamin D II ROCHE DIAGNOSTICS GMBH 07/10/2021 Valid
NAVIFY MUTATION PROFILER
10287411586
Software II ROCHE SEQUENCING SOLUTIONS, INC. 09/09/2021 Valid
UC-DGN-ADVTM Adenovírus
10287411585
Not yet published II Not yet published 26/08/2021 Cancelled 29/01/2024
Elecsys Total-Tau CSF
10287411584
Tau protein II ROCHE DIAGNOSTICS GMBH 19/08/2021 Valid
Elecsys Phospho-Tau (181P) CSF
10287411583
Phosphorylated tau protein II ROCHE DIAGNOSTICS GMBH 19/08/2021 Valid
Elecsys ß-Amyloid (1-42) CSF II
10287411582
Beta-amyloid protein II ROCHE DIAGNOSTICS GMBH 19/08/2021 Valid
Elecsys PTH (1-84)
10287411581
Intact parathyroid hormone (iPTH) II ROCHE DIAGNOSTICS GMBH 19/08/2021 Valid