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510(k) Data Aggregation
K Number
K250885Device Name
Ceftobiprole BPR 5 µg Disc
Manufacturer
Liofilchem Inc.
Date Cleared
2025-06-23
(90 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
Liofilchem Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Liofilchem Antibiotic Discs are a semi-quantitative agar diffusion method for in vitro determination of antimicrobial susceptibility of clinical isolates tested on agar media after overnight incubation.
The Ceftobiprole BPR 5 µg Disc is intended to determine susceptibility of Enterobacterales and Staphylococcus aureus to ceftobiprole, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). Ceftobiprole at concentrations of 5 μg should be interpreted at 16-18 hours of incubation.
The Ceftobiprole BPR 5 µg Disc demonstrated acceptable performance with the following organisms:
- Enterobacterales (Escherichia coli and Klebsiella pneumoniae)
- Staphylococcus aureus (includes methicillin resistant isolates)
Device Description
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