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510(k) Data Aggregation

    K Number
    K132491
    Device Name
    MUELLER HINTON AGAR
    Manufacturer
    EDGE BIOLOGICALS, INC.
    Date Cleared
    2014-06-30

    (326 days)

    Product Code
    JTZ
    Regulation Number
    866.1700
    Why did this record match?
    Product Code :

    JTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mueller Hinton Agar is a standard basal medium intended for in vitro antimicrobial disk diffusion susceptibility testing of isolated colonies of common, rapidly growing bacteria by the Bauer-Kirby method as standardized by the Clinical and Laboratory Standards Institute (CLSI). This product has not been evaluated for gradient diffusion testing.
    Device Description
    Mueller Hinton Agar is a standard basal medium intended for in vitro antimicrobial disk diffusion susceptibility testing of isolated colonies of common, rapidly growing bacteria by the Bauer-Kirby method standardized by the Clinical and Laboratory Standards Institute (CLSI). This product has not been evaluated for gradient diffusion testing. The Bauer-Kirby procedure is based on the diffusion through an agar gel of antimicrobial substances which are impregnated on sterile paper disks. This method employs disks with a sinqle concentration of antimicrobial agent and zone sizes are correlated with minimum inhibitory concentrations. In the test procedure, a standardized suspension of the organism is swabbed over the entire surface of the agar medium. Sterile paper disks impregnated with specified amounts of antibiotic or other antimicrobial agents are then placed on the surface of the inoculated agar medium. The agar medium is incubated at 35+ 2°C for 16-18 hours. The organism will grow as a solid "lawn". The antimicrobial will diffuse outward (in a circle). If the antimicrobial agent has activity against the organism, a circular zone of growth inhibition will result. The zone of inhibition around the paper disk is measured. A determination as to whether the organism is susceptible, intermediate or resistant to the antimicrobial agent is determined by comparing the size of the zone of inhibition to the zone diameter interpretive criteria in the CLSI M100 Standard.
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    K Number
    K963036
    Device Name
    MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Date Cleared
    1996-10-07

    (63 days)

    Product Code
    JTZ
    Regulation Number
    866.1700
    Why did this record match?
    Product Code :

    JTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INTENDED USE: Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood (MHLHB) is intended for use in broth dilution antimicrobial susceptibility testing of Streptococcus pneumoniae with 11 antimicrobial agents; i.e., cefaclor, cefotaxime, ceftriaxone, cefuroxime, chloramphenicol, ervthromvcin, imipenem, penicillin, tetracycline, trimethoprim/ sulfamethoxazole, and vancomycin, according to the protocol described in the Approved Standard M7-A3, "Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically - Third Edition", dated 12/93, published by the National Committee for Clinical Laboratory Standards (NCCLS). INDICATIONS FOR USE; Use of BBL® Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood is indicated when Streptococcus pneumoniae has been isolated in pure culture in the clinical laboratory, and a determination is desired as to whether the organism is susceptible, intermediate, or resistant to selected antimicrobial agents. In cases such as these, broth dilution antimicrobial susceptibility testing may be performed on BBL® Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood, using cefaclor, cefotaxime, ceftrixone, cefuroxime, chloramphenicol, erythromycin, imipenem, penicillin, tetracycline, trimethoprim/sulfamethoxazole, and vancomycin.
    Device Description
    Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood (MHLHB) is an Antimicrobial Susceptibility Culture Medium used for broth dilution antimicrobial susceptibility testing. It is a liquid medium used in tubes (macrodilution) or microtiter trays. The test involves inoculating serial dilutions of the drug in the medium and examining for the presence of growth after incubation to determine the minimal inhibitory concentration (MIC).
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    K Number
    K960420
    Device Name
    MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Date Cleared
    1996-04-04

    (66 days)

    Product Code
    JTZ
    Regulation Number
    866.1700
    Why did this record match?
    Product Code :

    JTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960313
    Device Name
    MUELLER HINTON AGAR WITH 2% NACI
    Manufacturer
    REMEL, L.P.
    Date Cleared
    1996-03-25

    (63 days)

    Product Code
    JTZ
    Regulation Number
    866.1700
    Why did this record match?
    Product Code :

    JTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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