Ceftobiprole BPR 5 µg Disc

The Ceftobiprole BPR 5 µg Disc is an antimicrobial susceptibility test disc used to determine if Enterobacterales and Staphylococcus aureus bacteria are susceptible to the antibiotic ceftobiprole. It employs a semi-quantitative agar diffusion method on agar media with overnight incubation at 16-18 hours and is intended for prescription use in clinical laboratories.

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The FDA determined substantial equivalence by comparing this device to legally marketed predicate antimicrobial susceptibility test discs that were on the market prior to May 28, 1976, or have been reclassified under the Federal Food, Drug, and Cosmetic Act. The device uses the same agar diffusion methodology and interpretation criteria (FDA STIC) as established predicates, with demonstrated acceptable performance on the specified organism types, establishing it as substantially equivalent without requiring a premarket approval application.