Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL

• K Number: K193024
• Device Name: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL
• Manufacturer: Thermo Fisher Scientific
• Date Cleared: 2020-01-08 ( 70 days)
• Product Code: JWY , LRG , LTT
• Regulation Number: 866.1640
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).