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    Check company, site and product certificates - Validation and Verification

    Roche Molecular Systems, Inc.

    Roche Molecular Systems, Inc.
    1080 US Highway 202 South
    Branchburg
    08876
    USA
    BSI logo

    Certificate number: CE 707974
    Scope: Design and manufacture of nucleic acid test kits for Donor Screening for HBV, HCV and HIV. Design and manufacture of nucleic acid test kits to aid in the diagnosis and management of disease status for HBV, HCV or HIV infected individuals. Design and manufacture of nucleic acid test kits to aid in the diagnosis and management of Cytomegalovirus in transplant patients and for detection of HCV, HBV, HIV-1, HIV-2 and Chlamydia Trachomatis.

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV Ex. 4&6 (H7) 2019-03-26 2025-05-26

    Certificate number: CE 708017
    Scope: COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, version 2.0

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-03-26 2025-05-26

    Certificate number: CE 708019
    Scope: cobas® HBV Quantitative nucleic acid test

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-03-26 2025-05-26

    Certificate number: CE 708020
    Scope: cobas® HCV Quantitative nucleic acid test

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-03-26 2025-05-26

    Certificate number: CE 708021
    Scope: cobas® MPX Multiplex HIV, HCV & HBV nucleic acid test

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-03-26 2025-05-26

    Certificate number: CE 708022
    Scope: cobas® HBV/HCV/HIV-1 Control Kit

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-03-26 2024-12-11

    Certificate number: CE 709225
    Scope: cobas® HIV-1 Quantitative nucleic acid test

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-03-26 2025-05-26

    Certificate number: CE 709228
    Scope: cobas® HBV/HCV/HIV-1 Control Kit

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-03-26 2025-05-26

    Certificate number: CE 709229
    Scope: cobas® HIV-1 Nucleic acid test for use on the cobas® 4800 System

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-03-26 2024-12-08

    Certificate number: CE 709230
    Scope: COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test, version 2.0

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-03-26 2025-05-26

    Certificate number: CE 709232
    Scope: cobas® HIV-1/HIV-2 Qualitative Nucleic acid test

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-05-02 2025-05-26

    Certificate number: CE 709234
    Scope: COBAS®AmpliPrep/COBAS®TaqMan HBV Test, version 2.0

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-03-26 2025-05-26

    Certificate number: CE 709235
    Scope: cobas® HBV Quantitative nucleic acid test for use on the cobas® 4800 System

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-04-10 2024-12-17

    Certificate number: CE 709237
    Scope: COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, v2.0

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-05-02 2025-05-26

    Certificate number: CE 709239
    Scope: COBAS® AmpliPrep /COBAS® TaqMan® HCV Qualitative Test v2.0

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-05-02 2025-05-26

    Certificate number: CE 709240
    Scope: cobas® HCV Quantitative nucleic acid test for use on the cobas® 4800 System

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-04-10 2024-12-17

    Certificate number: CE 709242
    Scope: cobas® HCV GT HCV genotyping test for use on the cobas® 4800 System

    Standard/Scheme number or name Start Date Expiry Date
    98/79/EC Annex IV, Sec. 4 (H6) 2019-04-10 2024-12-12

    Certificate number: IVDR 732732
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter I and III 2021-04-29 2026-04-28

    Certificate number: IVDR 732739
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2023-10-31 2028-10-30

    Certificate number: IVDR 732757
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2021-11-17 2026-11-16

    Certificate number: IVDR 732821
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2024-08-01 2029-07-31

    Certificate number: IVDR 732822
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2024-05-15 2029-05-14

    Certificate number: IVDR 732823
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2023-01-09 2028-01-08

    Certificate number: IVDR 732824
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2024-02-12 2029-02-11

    Certificate number: IVDR 732825
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2024-02-12 2029-02-11

    Certificate number: IVDR 732826
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2024-09-05 2029-09-04

    Certificate number: IVDR 732829
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2023-05-31 2028-05-30

    Certificate number: IVDR 732831
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2023-05-31 2028-05-30

    Certificate number: IVDR 732833
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2023-08-08 2028-08-07

    Certificate number: IVDR 732837
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2023-05-31 2028-05-30

    Certificate number: IVDR 732838
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2023-05-31 2028-05-30

    Certificate number: IVDR 732839
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2021-11-17 2026-11-16

    Certificate number: MDSAP 739944
    Scope: Manufacture, Quality and Complaint Management.

    Standard/Scheme number or name Start Date Expiry Date
    MDSAP 2018-07-01 2027-06-30

    Certificate number: MD 739945
    Scope: Design and manufacture of In Vitro Diagnostic Kits, integrated systems and associated software used in the diagnosis and management of disease status of infectious diseases, donor screening associated with infectious diseases, primary screening associated with oncogenic viruses, detection of biomarkers for companion diagnostics, microbiology, and genetic testing.

    Standard/Scheme number or name Start Date Expiry Date
    ISO 13485: 2016 2021-03-05 2027-06-30

    Certificate number: IVDR 749724
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2022-03-18 2027-03-17

    Certificate number: IVDR 752726
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2024-02-12 2029-02-11

    Certificate number: IVDR 752731
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2023-08-08 2028-08-07

    Certificate number: IVDR 752735
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2023-08-08 2028-08-07

    Certificate number: IVDR 782480
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2023-08-08 2028-08-07

    Certificate number: IVDR 791536
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2024-05-15 2029-05-14

    Certificate number: IVDR 802289
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2024-12-18 2029-12-17

    Certificate number: IVDR 802291
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2024-12-18 2029-12-17

    Certificate number: IVDR 804022
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2024-08-01 2029-07-31

    Certificate number: IVDR 805377
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/746 Annex IX Chapter II 2024-12-18 2029-12-17
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