BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PHAMATECH INC.

    Reg #: 2031229 · FEI: 3000719950 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    16
    Establishment Types
    5
    Classifications
    19

    Registration Details

    Registration Name
    PHAMATECH INC.
    Registration Number
    2031229
    FEI Number
    3000719950
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    15175 Innovation Dr
    City
    San Diego
    State
    CA
    ZIP
    92128
    Country
    US

    Regulatory Submissions

    510(k) Number
    K972556

    Owner / Operator

    Firm Name
    PHAMATECH INC.
    Operator Number
    9026390
    Address
    15175 Innovation Drive, --
    City
    San Diego
    State
    CA
    Postal Code
    92128
    Country
    US
    Correspondent
    Tuan H Pham

    Products

    Device Name Product Code
    Gas Chromatography, Methamphetamine LAF
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Enzyme Immunoassay, Opiates DJG
    Fluorometry, Morphine DJJ
    Thin Layer Chromatography, Amphetamine DIT
    Enzyme Immunoassay, Benzodiazepine JXM
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Kit, Test, Multiple, Drugs Of Abuse, Over The Counter MVO
    Radioimmunoassay, Luteinizing Hormone CEP
    Container, Specimen, Urine, Drugs Of Abuse, Over The Counter MPQ
    Visual, Pregnancy Hcg, Prescription Use JHI
    Enzyme Immunoassay, Phencyclidine LCM
    Thin Layer Chromatography, Cocaine DMN
    Enzyme Immunoassay, Barbiturate DIS
    Reagent, Coronavirus Serological QKO

    Proprietary Names

    QUICKSCREEN ONE STEP AT HOME QUICKCUP PREGNANCY TEST QuickStick Pregnancy Test ING TEST QUICKSCREEN ONE STEP OPIATE SCREEN QUICKSCREEN OXYCODONE TEST QuickScreen MOMENTS MENOPAUSE CHECK At Home OVUCARD LH TEST QUICKSCREEN ONE STEP THC TEST QUICKSCREEN HOME DRUG TEST SYSTEM QUICKSTICK PRO HCG TEST QUICKSCREEN ONE STEP PHE Phamatech's COVID-19 IgG / IgM Rapid Test at Home

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility