K-number	K243202
Device name	MTS Ceftobiprole 0.002-32 µg/mL
Applicant	Liofilchem s.r.l.
Product code	JWY
Device class	Class II
Decision date	Jan 30, 2025
Decision	Substantially Equivalent
Regulation	866.1640

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The MTS Ceftobiprole 0.002-32 µg/mL is a quantitative in vitro antimicrobial susceptibility test device consisting of specialized paper impregnated with a predefined concentration gradient of ceftobiprole. It determines the minimum inhibitory concentration (MIC) of ceftobiprole against bacteria including Escherichia coli, Klebsiella pneumoniae, and Staphylococcus aureus (including methicillin-resistant isolates) using overnight agar incubation and manual reading.

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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MTS Ceftobiprole 0.002-32 µg/mL

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