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510(k) Data Aggregation

    K Number
    K221493
    Device Name
    MicroScan Prompt Inoculation System-D
    Manufacturer
    Beckman Coulter, Inc.
    Date Cleared
    2023-04-05

    (317 days)

    Product Code
    LIE
    Regulation Number
    866.1640
    Why did this record match?
    Product Code :

    LIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroScan Prompt® Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility tests. The MicroScan Prompt Inoculation System-D is an accessory to the MicroScan Gram Negative and Gram Positive MIC/Combo Panels. Indications for use organisms are specific for each antimicrobial agent on the panel.
    Device Description
    The MicroScan Prompt Inoculation System-D is a method for obtaining standardized bacterial inoculum while eliminating the need for incubation and turbidity adjustment with inocula prepared according to the CLSI procedure. It consists of an inoculation wand and a bottle of diluent. The wand is a polypropylene rod with a breakaway collar that serves as a wiping mechanism. The rod is attached to a stopper. At the tip of the wand is a groove designed to hold a specific amount of bacteria equivalent to a 0.5 McFarland standard. Thirty (30) ml of diluent (Pluronic is used as the surfactant) are provided in the plastic bottle. Each kit contains 60 plastic bottles, each containing 30 ml of stabilized aqueous Pluronic surfactants and 62 inoculation wands.
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    K Number
    K103456
    Device Name
    THE SENSITITRE AIM
    Manufacturer
    TREK DIAGNOSTIC SYSTEMS
    Date Cleared
    2011-06-22

    (210 days)

    Product Code
    LIE, JWY, LRG
    Regulation Number
    866.1640
    Why did this record match?
    Product Code :

    LIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIM™ is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae, other Streptococci spp. and Candida spp.
    Device Description
    The Sensititre AIM™ is a microprocessor controlled instrument that delivers inoculum in 50ul multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension in accordance with the package insert. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the AIM's pump assembly. The inoculum is then dispensed into the microtitre plates.
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    K Number
    K110331
    Device Name
    SENSITITRE AIM (TM)
    Manufacturer
    TREK DIAGNOSTIC SYSTEMS, LTD.
    Date Cleared
    2011-04-27

    (83 days)

    Product Code
    LIE, JWY, LRG
    Regulation Number
    866.1640
    Why did this record match?
    Product Code :

    LIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIMTM is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious gram negative organisms.
    Device Description
    The Sensititre AIM™ is a microprocessor controlled instrument that delivers inoculum in 50ul multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension in accordance with the package insert. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the AIM's pump assembly. The inoculum is then dispensed into the microtitre plates.
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