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Found 23 results
510(k) Data Aggregation
K Number
K243202Device 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
866.1640Why 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
K211672Device 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
866.1640Why 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
K200180Device 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
866.1640Why 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
K192345Device 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
866.1640Why 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
K191809Device 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
866.1640Why 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
K190914Device 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
866.1640Why 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
K190252Device 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
866.1640Why 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
K183527Device 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
866.1640Why 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
K183115Device 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
866.1640Why 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
K182922Device 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
866.1640Why 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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