BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hydrogen Breath Test Collection Kit: Domestic SIBO 6-Tube (Lactulose)

    Reg #: 3009236726 · FEI: 3009236726 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
    Registration Number
    3009236726
    FEI Number
    3009236726
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4 Technology Way
    City
    Salem
    State
    MA
    ZIP
    01970
    Country
    US

    Owner / Operator

    Firm Name
    Commonwealth Diagnostics Intl, Inc.
    Operator Number
    10055546
    Address
    4 Technology Way
    City
    Salem
    State
    MA
    Postal Code
    01970
    Country
    US
    Correspondent
    Gray W Rifkin

    Products

    Device Name Product Code
    Container, Specimen, Non-Sterile NNI

    Proprietary Names

    Hydrogen Breath Test Collection Kit: Domestic SIBO 6-Tube (Lactulose) Hydrogen Breath Test Collection Kit: Sucrose 6-Tube Hydrogen Breath Test Collection Kit: Fructose 6-Tube Hydrogen and Methane Breath Test Collection Kit: Lactose 6-Tube Hydrogen and Methane Breath Test Collection Kit: Sucrose 6-Tube Hydrogen Breath Test Collection Kit: SIBO 10-Tube (Glucose) Hydrogen and Methane Breath Test Collection Kit: Fructose 6-Tube Hydrogen Breath Test Collection Kit: Domestic SIBO 10-Tube (Lactulose) Hydrogen and Methane Breath Test Collection Kit: SIBO 10-Tube (Glucose) Hydrogen and Methane Breath Test Collection Kit: SIBO 10-Tube (Lactulose) Hydrogen Breath Test Collection Kit: Lactose 6-Tube Hydrogen and Methane Breath Test Collection Kit: SIBO 6-Tube (Lactulose)

    Establishment Types

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