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299 devices foundsorted by relevance

Manufacturer: Roche Diagnostic Systems, Inc. Clear all

  • VENTANA PTEN (SP218) RxDx Assay

    Ventana Medical Systems, Inc. (Roche Tissue Diagnostics),FDA registration: United States
    Active Regimes: PMA Registry: PMA Class:—

  • Abuscreen(R) Radioimmun For Cocaine Metabolite

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cobas Core Immunochemistry System

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Roche Reagent For Apolipoprotein B

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Roche Abuscreen Ontrak Pos. Ref. Control-Methadone

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ontrak Testcup Amphetamines

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cobas Fp Reagen For Amikacin & Amikacin Calibrator

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Roche Reagent For Direct Bilirubin

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Abuscreen Online(R) Calibrators

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Abuscreen(R) Eia Amphetamine

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Abuscreen(R) Ontrak(Tm) For Morphine

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Roche Abuscreen Onlinne Calibrators

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Roche Reagent For Calcium

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Revised Labeling For Lsd Test Kit

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Roche Cobas Integra Analyzer, Reagent Cassettes Open recall

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Abuscreen(R) Online Calibrators

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Abuscreen Ontrak Pos. Reference Control For Thc

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Abuscreen Online Cannabinoids Positive Control

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cobas Reagents For Tobramycin & Calibra

    Roche Diagnostic Systems, Inc.,United States(FDA applicant)
    Active Regimes: 510(k) Registry: 510(k) Class:II

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