BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OraQuick Advance HIV 1/2 Kit Controls

    DI: 00608337000009 · Model: 1001-0077 · Orasure Technologies, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OraQuick Advance HIV 1/2 Kit Controls
    Primary DI
    00608337000009
    Version / Model
    1001-0077
    Company Name
    Orasure Technologies, Inc.
    Labeler DUNS
    114152184
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-05
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    2f68422f-d6e1-406c-9d73-00bd9c7f56b7

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MTL Monitor,Test,Hiv-1

    GMDN Terms

    Code Name
    48456 HIV1/HIV2 antibody IVD, control

    Identifiers

    Type ID
    Primary 00608337000009

    Customer Contacts

    Phone
    610-882-1820
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    BP010047 006
    BP010047 007
    BP010047 008
    BP010047 010
    BP010047 011
    BP010047 012
    BP010047 013
    BP010047 015
    BP010047 016
    BP010047 017
    BP010047 019
    BP010047 022
    BP010047 023
    BP010047 025
    BP010047 026
    BP010047 028
    BP010047 029
    BP010047 030
    BP010047 031
    BP010047 032
    BP010047 034
    BP010047 035
    BP010047 036
    BP010047 039
    BP010047 040
    BP010047 041
    BP010047 042
    BP010047 043
    BP010047 044
    BP010047 045
    BP010047 046
    BP010047 047
    BP010047 048
    BP010047 049
    BP010047 050
    BP010047 051
    BP010047 052
    BP010047 053
    BP010047 054

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius