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510(k) Data Aggregation

    K Number
    K103805
    Device Name
    MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
    Manufacturer
    MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD
    Date Cleared
    2011-01-25

    (28 days)

    Product Code
    LIO
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    **MEDICAL WIRE **& EQUIPMENT COMPANY (BATH) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medical Wire & Equipment Σ-Transwab (Sigma-Transwab ) Specimen Collection and Transport System is intended to preserve the viability and infectivity of microbiological specimens after their collection and during transport from the collection site to the testing laboratory. Σ-Transwab specimens are processed using standard clinical laboratory operating procedures for microbiological specimens.
    Device Description
    Not Found
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    K Number
    K082472
    Device Name
    VIROCULT, MODEL MW950
    Manufacturer
    MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD
    Date Cleared
    2008-12-30

    (124 days)

    Product Code
    LIO
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    **MEDICAL WIRE **& EQUIPMENT COMPANY (BATH) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medical Wire & Equipment Virocult® Virus Collection and Transport System is intended to preserve the viability and infectivity of viral specimens for viral culture after their collection and during transport from the collection site to the testing laboratory. Virocult specimens are processed using standard clinical laboratory operating procedures for viral and cell culture.
    Device Description
    Each Virocult® device comprises a sterile peel pouch containing a rayon- tipped swab used to collect the sample and a tube containing an open cell polyurethane pad soaked with Virocult® virus transport medium. After sampling, the swab applicator is placed inside the tube, where the bud is bathed with the liquid from the foam pad. Virocult® medium consists of a phosphate-buffered balanced salt solution, glucose, lactalbumin hydrolysate to stabilise the virus particles, and antibiotics to inhibit the growth of other microorganisms that may be present in the clinical specimen. The rayon- tipped swab will suit most general applications such as mouth, nose, throat and skin. To use Virocult®, the sterile peel pouch is opened, and the cap removed from the transport tube. The applicator swab is removed from the pouch and used to collect the clinical specimen. During specimen collection, the applicator should only fouch the area where the infection is suspected.
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