BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PEARL DIAGNOSTICS, INC.

    Reg #: 3022929618 · FEI: 3022929618 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    PEARL DIAGNOSTICS, INC.
    Registration Number
    3022929618
    FEI Number
    3022929618
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1812 Ashland Ave Ste G32
    City
    Baltimore
    State
    MD
    ZIP
    21205
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243496

    Owner / Operator

    Firm Name
    Pearl Diagnostics, Inc.
    Operator Number
    10086492
    Address
    1812 ASHLAND AVE, Suite G32
    City
    Baltimore
    State
    MD
    Postal Code
    21205
    Country
    US
    Correspondent
    Irina Baburina

    Products

    Device Name Product Code
    Antigen, Galactomannan, Aspergillus Spp. NOM
    Strip, Hama Igg, Elisa, In Vitro Test System MLH

    Proprietary Names

    MycoMEIA® Aspergillus Assay

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only