BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MAINE MOLECULAR QUALITY CONTROLS, INC.

    Reg #: 3005959679 · FEI: 3005959679 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    MAINE MOLECULAR QUALITY CONTROLS, INC.
    Registration Number
    3005959679
    FEI Number
    3005959679
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    23 Mill Brook Rd
    City
    Saco
    State
    ME
    ZIP
    04072
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230868

    Owner / Operator

    Firm Name
    MAINE MOLECULAR QUALITY CONTROLS, INC.
    Operator Number
    9081510
    Address
    23 Mill Brook Road, Mill Brook Business Park
    City
    Saco
    State
    ME
    Postal Code
    04072
    Country
    US

    Products

    Device Name Product Code
    Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays PMN
    Multi-Analyte Controls Unassayed OHQ
    Quality Control Material, Genetics, Rna QIG
    Quality Control Material, Genetics, Dna NZB

    Proprietary Names

    SPOTFIRE RSP Positive Control FilmArray Warrior Control Panel M290 FilmArray GI Control Panel M238 Birlinn™ CoV2-Flu-RSV Control Panel M509 SPOTFIRE RSP Negative Control SPOTFIRE RSP Pos & Neg Controls FilmArray BCID2 Control Panel M416 BioFire JI Control Panel M420 BioFire RP2.1/RP2.1plus Control Panel M441 Xpert BCR-ABL IS Panel C130 Xpert BCR-ABL 0%IS Xpert BCR-ABL IS p210 Linearity Panel C207 Birlinn BCR-ABL1 p210 IS Control Panel C240 Xpert BCR-ABL IS p210 Panel C206 Birlinn BCR-ABL1 p210 IS Panel C230 INTROL CF Panel I Control v2 FilmArray Pneumonia/Pneumoniaplus Control

    Establishment Types

    Manufacture Medical Device