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510(k) Data Aggregation
K Number
K200308Device Name
MTS Lefamulin 0.016- 256 µg/mL
Manufacturer
Date Cleared
2020-04-06
(60 days)
Product Code
Regulation Number
866.1640Why did this record match?
Applicant Name (Manufacturer) :
Liofilchem s. r. 1.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MTS (MC Test Strip) Lefamulin 0.016 - 256 µg/mL is a quanttative method intended for the in vitro determination of animicrobal 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 ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Lefamilin at concentrations of 0.016 - 256 ug/mL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation.
Lefamulin has been shown to be active both clinically and in viro against these bacterial species according to the FDA drug approved label:
Gram-positive bacteria Streptococcus pneumoniae Staphylococcus aureus (methicillin-susceptible isolates)
Gram-Negative bacteria Haemophilus influenzae
Device Description
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 ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
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