K-number	K243169
Device name	The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL
Applicant	Thermo Fisher Scientific
Product code	JWY
Device class	Class II
Decision date	Dec 19, 2024
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 Ceftobiprole is an in vitro diagnostic device for clinical susceptibility testing of non-fastidious bacterial isolates. It tests ceftobiprole at dilution ranges of 0.008-16 µg/mL against Staphylococcus aureus, including methicillin-resistant isolates, to determine antibiotic susceptibility.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

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 Ceftobiprole in the dilution range of 0.008-16 ug/mL

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