BEUDAMED
    FDA Registration Active 🇺🇸 United States

    The Dot Printer Inc.

    Reg #: 3011057574 · FEI: 3011057574 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    The Dot Printer Inc.
    Registration Number
    3011057574
    FEI Number
    3011057574
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9700 Toledo Way
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192920

    Owner / Operator

    Firm Name
    The Dot Corp
    Operator Number
    10049851
    Address
    9700 Toledo Way
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Jeffrey O Shattuck

    Products

    Device Name Product Code
    Urine Collection Kit (Excludes Hiv Testing) OIE
    Dna Specimen Collection, Saliva OYJ
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF
    Blood And Urine Collection Kit (Excludes Hiv Testing) OIB
    Reagents, Non-Variola Orthopoxvirus Nucleic Acid. QTQ
    Blood Specimen Collection Convenience Kit (Excludes Hiv) PQD
    Blood Specimen Collection Kit (Excludes Hiv Testing) OFZ
    Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile NNL

    Proprietary Names

    LABCORP Microalbumin Kit UTI Convenience Kit LABCORP Fit KIT Alinity M Resp 4plex AMP Kit STI COLLECTION KIT T1 Diabetes Biomark Test

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device