BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BAEBIES INC.

    Reg #: 3011240982 · FEI: 3011240982 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    11

    Registration Details

    Registration Name
    BAEBIES INC.
    Registration Number
    3011240982
    FEI Number
    3011240982
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    25 Alexandria Way
    City
    Durham
    State
    NC
    ZIP
    27703
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201049

    Owner / Operator

    Firm Name
    BAE-B01
    Operator Number
    10049734
    Address
    25 Alexandria Way Durham, NC 27703 USA
    City
    Durham
    State
    NC
    Postal Code
    27703
    Country
    US

    Products

    Device Name Product Code
    Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening JBF
    General Purpose Reagent PPM
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Reagents, Specific, Analyte MVU
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF
    Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative JBL
    Alpha-D-Galactosidase A (Gla) Newborn Screening Test System PQW
    ß-Glucocerebrosidase (Gba) Newborn Screening Test System PQV
    Alpha-L-Iduronidase (Idua) Newborn Screening Test System PQT
    Alpha-D-Glucosidase (Gaa) Newborn Screening Test System PQU
    Station, Pipetting And Diluting, For Clinical Use JQW

    Proprietary Names

    FINDER G6PD Test System, Baebies, Finder GENERAL PURPOSE REAGENT ANALYTE SPECIFIC REAGENT FINDER Flu A&B/SARS-CoV-2 SEEKER

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only