BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORASURE TECHNOLOGIES, INC.

    Reg #: 3003297763 · FEI: 3003297763 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    ORASURE TECHNOLOGIES, INC.
    Registration Number
    3003297763
    FEI Number
    3003297763
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    150 WEBSTER ST
    City
    Bethlehem
    State
    PA
    ZIP
    18015
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN190025
    PMA Number
    BP010047

    Owner / Operator

    Firm Name
    ORASURE TECHNOLOGIES, INC.
    Operator Number
    9000083
    Address
    220 EAST FIRST STREET, --
    City
    Bethlehem
    State
    PA
    Postal Code
    18015
    Country
    US
    Correspondent
    Tiffany A Miller

    Products

    Device Name Product Code
    Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test QSU
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus MZO
    Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens QID
    Coronavirus Antigen Detection Test System. QKP
    Hiv Self-Tests QSS

    Proprietary Names

    OraQuick ADVANCE Rapid HIV 1/2 OraSure HIV-1 Oral Specimen Collection Device OraQuick HCV Rapid Antibody Test OraQuick Ebola Rapid Antigen Test InteliSwab COVID-19 Rapid Test Pro InteliSwab COVID-19 Rapid Test InteliSwab COVID-19 Rapid Test Rx OraQuick In-Home HIV test OraQuick HIV Self-Test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device