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510(k) Data Aggregation

    K Number
    K243202
    Device Name
    MTS Ceftobiprole 0.002-32 µg/mL
    Manufacturer
    Liofilchem s. r. l.
    Date Cleared
    2025-01-30

    (121 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liofilchem s. r. l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MTS (MIC Test Strip) Ceftobiprole (BPR) 0.002-32 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a predefined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Ceftobiprole at concentrations of 0.002-32 µg/mL should be interpreted at 16-20 hours of incubation. MTS BPR can be used to determine the MC of ceftobioprole against the following microorganisms for which ceftobiprole has been shown to be active both clinically and/or in vitro according to the FDA drug approved label: Escherichia coli Klebsiella pneumoniae Staphylococcus aureus (includes methicillin resistant isolates)
    Device Description
    MTS consists of specialized paper impregnated with a predefined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
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    K Number
    K211672
    Device Name
    MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
    Manufacturer
    Liofilchem S. R. L.
    Date Cleared
    2021-10-20

    (141 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liofilchem S. R. L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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    K Number
    K200180
    Device Name
    MTS Omadacycline 0.002 - 32 ug/mL
    Manufacturer
    Liofilchem s. r. l.
    Date Cleared
    2020-03-20

    (56 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liofilchem s. r. l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MTS (MIC Test Strip) Omadacycline 0.002 - 32 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTSTM consists of specialized paper impregated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum infortory concentration (MC) in ugimL of antimicrobial agents agamst bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Omadacycline at concentrations of 0.002 - 32 ugimL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation. Omadacycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: Gram-Positive bacteria Staphylococcus aureus Staphylococcus lugdunensis Enterococcus faecalis Streptococcus pneumoniae Streptococcus pyogenes Streptococcus anginosus group (includes S. anginosus and S. constellatus) Gram-Negative bacteria Enterobacter cloacae Klebsiella pneumoniae Haemophilus influenzae Haemophilus parainfluenzae Omalacycline has been shown to be active in vitro only against the bacterial species listed below according to the FDA drug approved label: Gram-Positive bacteria Enterococcus faecium (vancomycin-susceptible and -resistant isolates) Gram-Negative bacteria Escherichia coli Citrobacter freundii Citrohacter koseri lebstella aerogenes
    Device Description
    Not Found
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    K Number
    K192345
    Device Name
    MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
    Manufacturer
    Liofilchem s. r. l.
    Date Cleared
    2019-10-31

    (63 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liofilchem s. r. l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MTS (MC Test Strip) Ampicilin-sulbactarn 0.016/0.08 - 256/128 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ugimL of animicrobial agents as tested on agar media using overnight incubation and manual reading procedures. MTS Ampicillin-sulbactam at concentrations of 0.016/0.008 - 256/128 ug/mL should be interpreted at 16-20 hours of incubation. Ampicillin-sulbactam has been shown to be active both clinically and in viro against these bacterial species according to the FDA drug approved label: Gram-negative bacteria Enterobacter asburiae Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Acinetobacter baumannii/Acinetobacter calcoaceticus complex Ampicillin'sulbactam has been shown to be active in viro only against the non-fastidious bacteria listed below according to the FDA drug approved label: Gram-negative bacteria Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii
    Device Description
    MTS (MC Test Strip) Ampicilin-sulbactarn 0.016/0.08 - 256/128 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ugimL of animicrobial agents as tested on agar media using overnight incubation and manual reading procedures.
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    K Number
    K191809
    Device Name
    MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
    Manufacturer
    Liofilchem s. r. l.
    Date Cleared
    2019-08-23

    (49 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liofilchem s. r. l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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    K Number
    K190914
    Device Name
    MTS Doxycycline 0.016 - 256 µg/mL
    Manufacturer
    Liofilchem s. r. l.
    Date Cleared
    2019-05-29

    (51 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liofilchem s. r. l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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    K Number
    K190252
    Device Name
    MTS Gentamicin 0.016 - 256 µg/mL
    Manufacturer
    Liofilchem s. r. l.
    Date Cleared
    2019-03-22

    (43 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liofilchem s. r. l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MTS (MIC Test Strip) Gentamicin 0.016-256 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Gentamicin at concentrations of 0.016-256 uq/mL should be interpreted at 16-20 hours of incubation. MTS Gentamicin can be used to determine the MIC of gentamicin aqainst the following bacteria. Gentamicin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: - Gram-negative bacteria Citrobacter freundii Citrobacter koseri Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia marcescens
    Device Description
    MTS consists of specialized paper impregnated with a pre-defined of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
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    K Number
    K183527
    Device Name
    MTS Ciprofloxacin 0.002 - 32 µg/mL
    Manufacturer
    Liofilchem s. r. l.
    Date Cleared
    2019-03-19

    (90 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liofilchem s. r. l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MTS™ (MIC Test Strip) Ciprofloxacin 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTS™ consists of specialized paper impremated with a pre-defined concentration eradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents as tested on agar media using overnight incubation and manual reading procedures. MTS™ Ciprofloxacin at concentrations of 0.002 - 32 ug/mL should be interpreted at 16-20 hours of incubation. MTS™ Ciprofloxacin can be used to determine the MIC of ciprofloxacin against the following bacteria. Ciprofloxacin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved abel: Gram-negative bacteria Citrobacter freundii Citrobacter koseri Enterobacter cloacae Escherichia coli Morganella morganii Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Serratia marcescens
    Device Description
    MTS™ consists of specialized paper impremated with a pre-defined concentration eradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents as tested on agar media using overnight incubation and manual reading procedures.
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    K Number
    K183115
    Device Name
    MTS Levofloxacin 0.002 - 32 µg/mL
    Manufacturer
    Liofilchem s. r. l.
    Date Cleared
    2018-12-20

    (41 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liofilchem s. r. l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MTSTM (MIC Test Strip) Levofloxacin 0.002-32 ug/mL is a quantitative method intended for the in viro determination of antimicrobial susceptbility of bacteria. MTS™ consists of specialized paper impremated with a pre-defined concentration eracient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents as tested on agar media using overnight incubation and manual reading procedures. MTS™ Levofloxacin at concentrations of 0.002 - 32 ug/mL should be interpreted at 16-20 hours of incubation. MTSTM Levofloxacin can be used to determine the MIC of levofloxacin against the following bacteria. Levofloxacin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved abel: Gram-negative bacteria Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens Levofloxacin has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label: Gram-negative bacteria Citrobacter freundii Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii
    Device Description
    MTS™ consists of specialized paper impremated with a pre-defined concentration eracient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents as tested on agar media using overnight incubation and manual reading procedures.
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    K Number
    K182922
    Device Name
    MTS Omadacycline 0.002-32 µg/mL
    Manufacturer
    Liofilchem s. r. l.
    Date Cleared
    2018-12-14

    (56 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liofilchem s. r. l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Liofilchem® MTS™ (MIC Test Strip) Omadacycline 0.002-32 ug/mL is a quantiative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine thilotiory concentration (MC) in ug/mL of antimicrobial agents against baceria as tested on agar media using overnight incubation and manual reading procedures. The MTSTM Omadacycline at concentrations of 0.002-32 µg/mL should be interpreted at 16-20 hours of incubation. MTS™ Omadacycline can be used to determine the MC of ornadacycline against the following bacteria. Omadacycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: Gram-Positive bacteria Staphylococcus aureus Staphylococcus lugdunensis Enterococcus faecalis Gram-Negative bacteria Enterobacter cloacae Klebsiella pneumoniae Omadacycline has been shown to be active in vitro only against the non-fastilous bacteria listed below according to the FDA drug approved label: Gram-Positive bacteria Enterococcus faecium (vancomycin-susceptible and -resistant isolates) Gram-Negative bacteria Escherichia coli Citrobacter freundii Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca
    Device Description
    MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine thilotiory concentration (MC) in ug/mL of antimicrobial agents against baceria as tested on agar media using overnight incubation and manual reading procedures.
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