BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY

    K Number: DEN140004 · Decision May 13, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    8
    Applicant Total
    37
    Review Days
    81

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    Basic Information

    Device Name
    QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
    K Number
    DEN140004
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.3309
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Diagnostic Hybrids, Inc.
    Date Received
    February 21, 2014
    Decision Date
    May 13, 2014
    Product Code
    PGI
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

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    Other Clearances by Diagnostic Hybrids, Inc.

    K Number Device Name
    K092229 THYRETAIN TM TSI REPORTER BIOASSAY
    K093415 D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
    K093233 D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
    K092882 D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
    K091171 D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
    K092300 MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
    K091753 ELVIS HSV ID AND D3 TYPING TEST SYSTEM
    K083391 THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
    K090073 D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
    K081746 D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
    Search all 37 clearances from Diagnostic Hybrids, Inc. →