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 16 of 36, highest registration number first)

ProductDevice typeClass ManufacturerPublishedStatus
PreciControl AMH
10287411080
Not yet published II Not yet published 15/12/2014 Cancelled 21/09/2026
AMH CalSet
10287411079
Not yet published II Not yet published 15/12/2014 Cancelled 10/11/2025
Elecsys AMH
10287411078
Not yet published II Not yet published 15/12/2014 Cancelled 10/11/2025
MRSA/SA Controls and Cofactor Kit
10287411077
Staphylococcus spp. III ROCHE MOLECULAR SYSTEMS, INC 15/12/2014 Until 15/12/2034
COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, v2.0
10287411076
Not yet published IV Not yet published 15/12/2014 Cancelled 30/09/2024
cobas 4800 System Internal Control Kit 1
10287411075
Combined parameters in one product - class III III ROCHE MOLECULAR SYSTEMS, INC 08/12/2014 Until 08/12/2034
MRSA/SA Amplification/Detection Kit
10287411074
Staphylococcus spp. III ROCHE MOLECULAR SYSTEMS, INC 08/12/2014 Until 08/12/2034
COBAS 6500
10287411073
Urine analyzer II ROCHE DIAGNOSTICS GMBH 03/11/2014 Valid
Cobas 4800 System Lysis Kit 1
10287411072
Buffers, diluents and other solutions for laboratory analysis I ROCHE MOLECULAR SYSTEMS, INC 03/11/2014 Valid
COBAS AmpliPrep/COBAS TaqMan Specimen Diluent Kit
10287411071
Not yet published I Not yet published 03/11/2014 Cancelled 29/12/2025
COBAS AmpliPrep/COBAS TaqMan Specimen Pre-Extraction Reagent
10287411070
Not yet published I Not yet published 03/11/2014 Cancelled 27/04/2026
HSV 1 and 2 Amplification/Detection Kit
10287411069
Herpes simplex virus (HHV-2) III ROCHE MOLECULAR SYSTEMS, INC 03/11/2014 Until 03/11/2034
C.f.a.s. IgA/IgM CSF
10287411068
Combined parameters in one product - class II II ROCHE DIAGNOSTICS GMBH 03/11/2014 Valid
Cdiff Amplification/Detection Kit
10287411067
Clostridium difficile (Clostridioides difficile) III ROCHE MOLECULAR SYSTEMS, INC 03/11/2014 Until 09/06/2035
HSV 1 and 2 Controls and Cofactor Kit
10287411066
Herpes simplex virus (HHV-2) III ROCHE MOLECULAR SYSTEMS, INC 03/11/2014 Until 03/11/2034
Cdiff Controls and Cofactor Kit
10287411065
Clostridium difficile (Clostridioides difficile) III ROCHE MOLECULAR SYSTEMS, INC 03/11/2014 Until 07/07/2035
Accu-Chek Tender Link
10287411064
Not yet published II Not yet published 03/11/2014 Cancelled 26/11/2017
Accu-Chek FlexLink
10287411063
Not yet published II Not yet published 03/11/2014 Cancelled 26/11/2017
Cobas TaqScreen MPX Test, v2.0
10287411062
HIV, HBV and HCV nucleic acid IV ROCHE MOLECULAR SYSTEMS, INC 29/09/2014 Until 29/09/2034
ACCU-CHEK PERFORMA CONNECT
10287411061
Not yet published III Not yet published 29/09/2014 Cancelled 26/11/2017
PreciControl Syphilis
10287411060
Treponema pallidum total antibodies IV ROCHE DIAGNOSTICS GMBH 22/09/2014 Until 22/09/2034
Elecsys Syphilis
10287411059
Treponema pallidum total antibodies IV ROCHE DIAGNOSTICS GMBH 22/09/2014 Until 22/09/2034
Cobas® TaqScreen MPX Control Kit, v2.0
10287411058
HIV, HBV and HCV nucleic acid IV ROCHE MOLECULAR SYSTEMS, INC 22/09/2014 Until 22/09/2034
Diluent Universal 2
10287411057
Buffers, diluents and other solutions for laboratory analysis I ROCHE DIAGNOSTICS GMBH 25/08/2014 Valid
Accu-chek performa
10287411056
Not yet published III Not yet published 04/08/2014 Cancelled 26/11/2017
ACCU-CHEK FASTCLIX LANCETADOR
10287411055
Not yet published I Not yet published 04/08/2014 Cancelled 26/11/2017
cobas HbA1c Control
10287411054
Not yet published II Not yet published 21/07/2014 Cancelled 21/09/2026
cobas Lipid Panel
10287411053
Total cholesterol II ROCHE DIAGNOSTICS GMBH 21/07/2014 Valid
Cystatin C Control Set Gen 2
10287411052
Cystatin C II ROCHE DIAGNOSTICS GMBH 21/07/2014 Valid
Cystatin C Gen.2
10287411051
Cystatin C II ROCHE DIAGNOSTICS GMBH 14/07/2014 Valid
C.f.a.s. Cystatin C
10287411050
Cystatin C II ROCHE DIAGNOSTICS GMBH 14/07/2014 Valid
MOV1LAB
10287411049
Not yet published I Not yet published 14/07/2014 Cancelled 27/04/2026
COBAS B101
10287411048
Analyzer for general chemistry, hormones, drugs or proteins II ROCHE DIAGNOSTICS GMBH 10/06/2014 Valid
Cobas HbA1c Test
10287411047
Not yet published II Not yet published 02/06/2014 Cancelled 01/09/2026
Cobas Lipid Control
10287411046
Not yet published II Not yet published 26/05/2014 Cancelled 21/09/2026
IgM CSF
10287411045
Immunoglobulin M II ROCHE DIAGNOSTICS GMBH 28/04/2014 Valid
IgA CSF
10287411044
Immunoglobulin A II ROCHE DIAGNOSTICS GMBH 28/04/2014 Valid
FAMÍLIA PRÉ ANALÍTICO COBAS P
10287411043
Sample preparation and processing instrument - pre-analytical phase I ROCHE DIAGNOSTICS GMBH 28/04/2014 Valid
CINtec PLUS Cytology Kit
10287411042
Human papillomavirus (HPV) III ROCHE DIAGNOSTICS GMBH 22/04/2014 Until 22/04/2034
Tina-quant Kappa Gen.2
10287411041
Not yet published II Not yet published 22/04/2014 Cancelled 09/06/2025
Cobas u pack
10287411040
Urine test strip II ROCHE DIAGNOSTICS GMBH 22/04/2014 Valid
Cobas u Calibration Strip
10287411039
Combined parameters in one product - class II II ROCHE DIAGNOSTICS GMBH 22/04/2014 Valid
Tina-quant Lambda Gen.2
10287411038
Not yet published II Not yet published 07/04/2014 Cancelled 09/06/2025
PreciControl Thyro Sensitive
10287411037
Combined parameters in one product - class III III ROCHE DIAGNOSTICS GMBH 24/03/2014 Until 08/09/2036
Elecsys Cyclosporine
10287411036
Cyclosporine III ROCHE DIAGNOSTICS GMBH 10/02/2014 Until 10/02/2034
Elecsys Tachrolimus
10287411035
Tacrolimus III ROCHE DIAGNOSTICS GMBH 10/02/2014 Until 10/02/2034
Preciset Lp(a) Gen.2
10287411034
Apolipoprotein A II ROCHE DIAGNOSTICS GMBH 30/12/2013 Valid
PreciControl Lp(a) Gen. 2
10287411033
Apolipoprotein A II ROCHE DIAGNOSTICS GMBH 30/12/2013 Valid
LPA2
10287411032
Apolipoprotein A-II II ROCHE DIAGNOSTICS GMBH 30/12/2013 Valid
LANCETAS COAGUCHEK
10287411031
Not yet published II Not yet published 23/12/2013 Cancelled 25/11/2019