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The Liofilchem® MTS™ (MIC Test Strip) Penicillin 0.002-32 µg/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 concentration gradient of an antimicrobial agent, which is used to determine the minibitory concentration (MC) in us/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The MTSTM Penicillin at concentrations of 0.002 - 32 ug/mL should be interpreted at 20-24 hours of incubation for Streptococcus spp.

MTS™ Penicillin can be used to determine the MIC of penicillin against the following bacteria. Penicillin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:

Streptococcus pneumoniae Streptococcus pyogenes (Group A ) Streptococcus dysgalactiae (Groups C & G) Streptococcus anginosus (Groups C & G) Streptococcus constellatus (Groups C & G) Streptococcus intermedius (Groups C & G)

MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minibitory concentration (MC) in us/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

This document is a marketing authorization for an antimicrobial susceptibility test. It does not contain information regarding studies to prove acceptance criteria for an AI/ML device. Therefore, I cannot extract the requested information.

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