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510(k) Data Aggregation

    K Number
    K222613
    Device Name
    ARX Liquid Amies Collection & Transport System
    Manufacturer
    ARX Sciences, Inc.
    Date Cleared
    2024-03-27

    (575 days)

    Product Code
    LIO, JTW, JTX
    Regulation Number
    866.2900
    Why did this record match?
    Product Code :

    LIO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARX Liquid Amies Collection & Transport System (ARX) is intended for use in the collection of clinical specimens (i.e., nasal secretion/wash; lachrymal secretion/tears; auricular secretion/cerumen; urethral, rectal, or vaginal swab; wound/abscess material) potentially containing aerobic, and fastidious bacteria and their transport at 2-8°C or 25-30°C from the patient to the laboratory for bacteriological examination and culture. In the laboratory, the collected and transported clinical specimens of nasal, lachrymal, ceruminous, vaginal, urethral, rectal, and wound/abscess origin are processed using standard clinical laboratory operating procedures for bacterial culture.
    Device Description
    The ARX Liquid Amies Collection & Transport System consists of a polypropylene screw-cap vial containing Liquid Amies transport medium and three (3) sterile peel-open pouches containing a pre-scored Microbrush nylon flocked swab for collecting specimens. The three (3) nylon flocked swabs are provided with various score points, tip sizes, and configurations to facilitate specimen collection from various sites on patients' bodies. Nylon flocked swabs facilitate quick absorption and release of clinical specimens. Proper specimen collection from the patient is critical for successful isolation and identification of infectious organisms. Amies liquid medium is a non-nutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, and magnesium chloride to provide essential ions that help maintain osmotic balance and control permeability of bacterial cells. It also contains sodium thioglycolate to provide a reduced environment. ARX Liquid Amies transport medium is capable of maintaining the viability of aerobic, anaerobic, and fastidious bacteria (such as Neisseria gonorrhoeae) during specimen transport to the laboratory for bacteriological testing and culture. All raw materials used in the manufacture of ARX Liquid Amies Collection & Transport System are qualified before use. Every batch of ARX Liquid Amies Collection & Transport System is tested prior to release for sterility, pH, and background count using microscopic examination. Representative samples of each batch are further evaluated for their ability to maintain the viability of selected bacterial agents over predefined time periods.
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    K Number
    K131630
    Device Name
    PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
    Manufacturer
    PURITAN MEDICAL PRODUCTS LLC
    Date Cleared
    2013-10-21

    (139 days)

    Product Code
    LIO, JTW, JTX
    Regulation Number
    866.2900
    Why did this record match?
    Product Code :

    LIO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Puritan® Amies Medium Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.
    Device Description
    Puritan Amies Medium Collection and Transport System is comprised of a sterile peel pouch containing a rayon tipped swab applicator for collecting specimen and a polypropylene tube containing 4 ml of Amies medium with or without charcoal. The rayon tipped swab applicators are provided in different tip sizes to accommodate various specimen types. Amies medium is a nonnutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride and magnesium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semi-solid texture to the medium. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of aerobic and fastidious bacteria during the transport to the laboratory.
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    K Number
    K120846
    Device Name
    TRANSPORT CULTURE MEDIUM DEVICE
    Manufacturer
    PURITAN MEDICAL PRODUCTS LLC
    Date Cleared
    2012-06-08

    (80 days)

    Product Code
    LIO, JTW, JTX
    Regulation Number
    866.2900
    Why did this record match?
    Product Code :

    LIO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Puritan Liquid Amies Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.
    Device Description
    Puritan Liquid Amies Collection and Transport System is comprised of a sterile peel pouch containing a polyester flock swab applicator for collecting specimen and a polypropylene vial containing 1 ml of modified Amies liquid transport medium. The polyester flock swab applicators are provided in two different tip sizes to accommodate various specimen types. Amies liquid medium is a nonnutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride and magnesium chloride to provide essential ions that help maintain osmotic balance. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of aerobic, anaerobic and fastidious bacteria during the transport to the laboratory.
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    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?
    Product Code :

    LIO

    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?
    Product Code :

    LIO

    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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    K Number
    K070062
    Device Name
    COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
    Manufacturer
    DIESSE DIAGNOSTICA SENESE S.P.A
    Date Cleared
    2007-07-30

    (206 days)

    Product Code
    LIO, JTW
    Regulation Number
    866.2900
    Why did this record match?
    Product Code :

    LIO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coproset Salmonella: In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp. Coproset Shigella: In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp Uriset preservative tubes: Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory. Swab set General Use: Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae.
    Device Description
    Coproset: disposable in vitro diagnostic device for the collection and transportation of stool samples and the enrichment of pathogenic organisms present in the sample. Coproset Salmonella: In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp. Coproset Shigella: In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp. Uriset Preservative tubes with holder: Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory. Swab set General use: Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae.
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    K Number
    K013711
    Device Name
    BACTI-SWAB DRY
    Manufacturer
    REMEL CO.
    Date Cleared
    2001-11-26

    (19 days)

    Product Code
    LIO
    Regulation Number
    866.2900
    Why did this record match?
    Product Code :

    LIO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REMEL's Bacti-Swab™ Dry collection and transport system is comprised of a sterile, rayon-tipped plastic shaft swab in a plastic sleeve for use in collection and transportation of a variety of samples to the laboratory for microbiological examination when dry swab collection is appropriate.
    Device Description
    comprised of a sterile, rayon-tipped plastic shaft swab in a plastic sleeve
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    K Number
    K003761
    Device Name
    NAT - NUCLEIC ACID TRANSPORT
    Manufacturer
    MEDICAL PACKAGING CORP.
    Date Cleared
    2001-05-31

    (176 days)

    Product Code
    LIO
    Regulation Number
    866.2900
    Why did this record match?
    Product Code :

    LIO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983119
    Device Name
    ENTERO-TEST HP, MODEL #102-01
    Manufacturer
    HDC CORP.
    Date Cleared
    1999-03-15

    (188 days)

    Product Code
    LIO
    Regulation Number
    866.2900
    Why did this record match?
    Product Code :

    LIO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Entero-Test® HP is an in-vitro diagnostic device to be used for the collection of fluid/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. The device consists of a nylon thread, 90cm in length, coiled inside a #00 gelatin pharmaceutical capsule.
    Device Description
    The Entero-Test® HP is collection device encased in a gelatin capsule. It can be used to collect fluids/mucous in the upper gastrointestinal tract of adults. A pH stick and a color chart are included in each package for the purpose of identifying the pH of the fluids/mucous.
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    K Number
    K981391
    Device Name
    PAR-ONE
    Manufacturer
    REMEL, INC.
    Date Cleared
    1998-07-14

    (88 days)

    Product Code
    LIO
    Regulation Number
    866.2900
    Why did this record match?
    Product Code :

    LIO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REMEL's Par-One™ is a medium recommended for use in qualitative procedures for the transportation, preservation, and examination of stool specimens for intestinal parasites. Concentration, permanent stained smear, and immunoassay procedures can be performed from this single vial transport system.
    Device Description
    Not Found
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