BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORASURE TECHNOLOGIES, INC.

    Reg #: 3022474803 · FEI: 3022474803 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    28
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    ORASURE TECHNOLOGIES, INC.
    Registration Number
    3022474803
    FEI Number
    3022474803
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2685 Opus Way, --
    City
    Bethlehem
    State
    PA
    ZIP
    18020
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN190025
    PMA Number
    P080027

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

    Proprietary Names

    OraQuick HCV Rapid Antibody Test OraQuick In-Home HIV test OraQuick HIV Self-Test OraQuick Ebola Rapid Antigen Test Oragene Dx (OGD-500, OGD-575) OraSure HIV-1 Oral Specimen Collection Device OraQuick ADVANCE Rapid HIV 1/2 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) Oragene Dx (OGD-500, OGD-510, OGD-575, OGD-600, OGD-610, OGD-675) ORAcollect RNA (OR-10; ORE-100) OMNIgene ORAL (OM-505, OME-505) ORAcollect Dx (OCD-100, OCD-100A) OMNIgene-GUT (OMD-200) OMNIgene VAGINAL (OMR-130) OMNIgene GUT (ME-200) OMNIgene GUT (OMR-200) OMNIgene SKIN (OMR-140) OMNIgene ORAL (OM-501, OMR-110, OMR-120) Oragene RNA (RE-100) Oragene DISCOVER (OGR-250, OGR-500, OGR-575, OGR-600, OGR-675) ORAcollect for Pediatrics (OC-175) InteliSwab COVID-19 Rapid Test Pro InteliSwab COVID-19 Rapid Test InteliSwab COVID-19 Rapid Test Rx Oragene Dx (OGD-510, OGD-600, OGD-610, OGD-675)

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device