BEUDAMED
    FDA Registration Active 🇺🇸 United States

    60-NF0636 Pointe Norfentanyl Level 2 Control (6.25 ng/mL)

    Reg #: 1827821 · FEI: 1827821 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HORIBA INSTRUMENTS INCORPORATED
    Registration Number
    1827821
    FEI Number
    1827821
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5449 RESEARCH DRIVE
    City
    Canton Twp
    State
    MI
    ZIP
    48188
    Country
    US

    Owner / Operator

    Firm Name
    HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical
    Operator Number
    10083022
    Address
    9755 Research Drive
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    Products

    Device Name Product Code
    Drug Specific Control Materials LAS

    Proprietary Names

    60-NF0636 Pointe Norfentanyl Level 2 Control (6.25 ng/mL) 60-MB0756 Pointe Carisporodol Metabolite (SOMA) Control (125 ng/mL) Level 2 60-MM0394 Pointe Methadone Metabolite (EDDP) Control (225 ng/mL) Level 1 60-MM0396 Pointe Methadone Metabolite (EDDP) Control (375 ng/mL) Level 2 60-MM0416 Pointe Methadone Metabolite (EDDP) Control (125 ng/mL) Level 2 60-MM0414 Pointe Methadone Metabolite (EDDP) Control (75 ng/mL) Level 1 60-NF0634 Pointe Norfentanyl Level 1 Control (3.75 ng/mL) 60-MB0754 Pointe Carisporodol Metabolite (SOMA) Control (75 ng/mL) Level 1

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198