BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORASURE TECHNOLOGIES INC.

    Reg #: 3004142665 · FEI: 3004142665 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    ORASURE TECHNOLOGIES INC.
    Registration Number
    3004142665
    FEI Number
    3004142665
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    220 EAST FIRST STREET
    City
    BETHLEHEM
    State
    PA
    ZIP
    18015
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN190025
    PMA Number
    BP910001

    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
    Dna Specimen Collection, Saliva OYJ
    Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples QPO
    Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test QSU
    Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens QID
    Coronavirus Antigen Detection Test System. QKP
    Hiv Self-Tests QSS
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus MZO

    Proprietary Names

    ORAcollect DNA (ORE-100) ORAcollect DNA (OCR-100) Oragene DNA (OG-250, OG-500, OG-510, OG-575, OG-600, OG-610, OG-675) Oragene ONE (ON-500, ON-600) OMNIgene-GUT (OMD-200) OraSure HIV-1 Oral Specimen Collection Device OraQuick ADVANCE Rapid HIV 1/2 ORAcollect Dx (OCD-100, OCD-100A) 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 OraQuick HCV Rapid Antibody Test

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device