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510(k) Data Aggregation

    K Number
    K240235
    Device Name
    OmniTrans Transport System
    Manufacturer
    Shenzhen Dakewe Bio-engineering Co., Ltd.
    Date Cleared
    2024-08-19

    (203 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Dakewe Bio-engineering Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OmniTrans™ Transport System is intended for use in the collection of clinical specimens (i.e., sputum, throat/ oropharyngeal swab, whole blood, urine, skin lesion material or exudate) potentially containing viruses, chlamydiae, mycoplasma, or ureaplasma and in their transport from the collection site to the testing laboratory. The system can be processed using standard clinical laboratory operating procedures for culture of clinical specimens.
    Device Description
    OmniTrans™ Transport System includes a screw-cap tube containing transport medium, which can be supplied alone, or in a kit with one of two possible collection swab options in a sterile peel pouch or with two collection swabs in sterile peel pouches. The in-tube-only format contains labeled screw-cap tubes pre-filled with 1 mL, 1.5 mL, or 3 mL of transport medium. The in-kit screw-cap tube format is pre-filled with 1 or 3 mL of transport medium for safe transportation of biological specimens. The format in kit is supplied in pre-packaged collection sets containing one of the two swab types or both of two swab types: Minitip flocking swab with 8 cm breaking point. Regular flocking swab with 3 cm breaking point. A specimen bag, with appropriate biosafety warning labels, is also provided with the device for safe transportation of clinical specimens in the transport medium.
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    K Number
    K230035
    Device Name
    BioSci™ Disposable Virus Sampling Tubes
    Manufacturer
    Shenzhen Dakewe Bio-engineering Co., Ltd.
    Date Cleared
    2023-04-05

    (90 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Dakewe Bio-engineering Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioSci™ Disposable Virus Sampling Tube is intended for the collection and transport of clinical specimens containing viruses or chlamydiae from the collection site to the testing laboratory. The system can be processed using standard clinical laboratory operating procedures for culture of clinical specimens.
    Device Description
    BioSci Disposable Virus Sampling Tube includes a screw-cap tube containing transport medium which is divided into two formats – in kit and tube. The format in kit is supplied in pre-packaged collection sets containing one of the two swab types or both of two swabs types: 1. Minitip (2.5 mm tip) flocking swab with 8 cm breaking point, for nasopharyngeal specimen collection 2. Regular (5 mm tip) flocking swab with 3 cm breaking point, for oropharyngeal specimen collection The screw-cap tube in kit format is pre-filled with 1 or 3 mL of transport medium for safe transportation of biological specimen. The format in tube only contains labeled screw-cap tubes pre-filled with 1 mL, 1.5mL, 2 mL and 3 mL of transport medium.
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    K Number
    K220059
    Device Name
    Biosci™ Inactivated Transport Medium, Biosci™ ITM
    Manufacturer
    Shenzhen Dakewe Bio-engineering Co., Ltd.
    Date Cleared
    2023-01-19

    (374 days)

    Product Code
    QBD
    Regulation Number
    866.2950
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Dakewe Bio-engineering Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biosci™ Inactivated Transport Medium (Biosci™ ITM) is intended for the collection, stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA from the collection site to the testing laboratory. The specimen collected in Biosci™ ITM is suitable for use with compatible molecular assays.
    Device Description
    Biosci™ ITM contains a detergent and a protein denaturant to inactivate Flu A, lyse cells, disrupt lipid membranes, denature proteins and enzymes, and stabilize influenza A RNA. Therefore, Biosci™ ITM is not intended to be used for culture-based techniques. A specimen bag is also provided for safe transportation of specimens, as well as providing appropriate biosafety warning. Biosci™ ITM has different configurations: - A screw-cap tube filled with 1.0, 2.0, or 3.0 mL of Biosci™ ITM . - A screw-cap tube filled with a range of media and package with an oropharyngeal swab for . oropharyngeal specimen collection - . A screw-cap tube filled with a range of media and package with a nasopharyngeal swab for nasopharyngeal specimen collection - . A screw-cap tube filled with a range of media and package with a mid-turbinate swab for mid-turbinate specimen collection
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