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510(k) Data Aggregation

    K Number
    K221826
    Device Name
    BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
    Date Cleared
    2022-12-21

    (181 days)

    Product Code
    Regulation Number
    866.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    Becton Dickinson, and Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BD BBL Sensi-Disc Antimicrobial Susceptibility Test (AST) Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. BD BBL Sensi-Disc Cefiderocol Disc 30 uq (FDC-30) can be used to determine susceptibility to Cefiderocol against the following bacteria, as described in the FDA-approved package insert for this antimicrobial agent. Active in vitro and in Clinical Infections Against: Complicated Urinary Tract Infections, Including Pyelonephritis Gram-negative Bacteria Escherichia coli Enterobacter cloacae complex Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) Gram-negative Bacteria Acinetobacter baumannii complex Escherichia coli Enterobacter cloacae complex Klebsiella pneumoniae Pseudomonas aeruginosa Serratia marcescens Active in vitro Against: Citrobacter freundii complex Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia rettgeri
    Device Description
    The BD BBL™ Sensi-Disc™ Cefiderocol 30 µg (FDC30) device is a 6 mm disc prepared by impregnating high quality absorbent paper with accurately determined amounts of Cefiderocol. Discs are clearly marked on both sides with the code FDC30. The code designates the agent Cefiderocol (FDC) and the drug content (30 ug). BD BBL™ Sensi-Disc ™ Antimicrobial Susceptibility Test Discs are furnished in cartridges containing 50 discs each. The last disc in each cartridge is marked "X" and contains the drug as coded. BD BBLTM Sensi-Disc ™ Antimicrobial Susceptibility Test Discs can be dispensed using a BD BBLTM Sensi-Disc TM Dispenser.
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