K-number	K252062
Device name	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
Applicant	Thermo Fisher Scientific
Product code	JWY
Device class	Class II
Decision date	Sep 25, 2025
Decision	Substantially Equivalent
Regulation	866.1640

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin is an antimicrobial susceptibility testing device used to determine the minimum inhibitory concentration (MIC) or breakpoint categorization of colistin against bacterial isolates. The system is used by clinical laboratories to guide antimicrobial therapy decisions by measuring bacterial resistance to colistin in the dilution range of 0.12-16 μg/mL over an 18-24 hour period.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL

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