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BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221826

by Becton, Dickinson and Company

Identifiers

510(k) Number
K221826 FDA 510(k)
FDA Product Code
JTN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.1620 FDA 510(k)
Regulation Number
866.1620 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BD BBL Sensi-Disc Cefiderocol 30µg (FDC-30) is an antimicrobial susceptibility test disc used for determining bacterial susceptibility to cefiderocol. Classified under susceptibility test discs, it adheres to the standard definition of a disc diffusion method for evaluating antibiotic efficacy against microbial isolates in clinical microbiology settings.

This single-use, non-sterile disc is intended for use in microbiology laboratories to assess bacterial resistance patterns. Supplied in a ready-to-use format, it requires no additional preparation beyond adherence to standard disc diffusion protocols. The device is regulated under FDA 510(k) clearance (K221826) and falls under Class II medical devices, governed by regulation number 866.1620.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD BBL™ Sensi-Disc™ antimicrobial susceptibility test discs, BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) (K221826) — FDA 510(k ..., K221826 - BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30), BD (company) - Wikipedia

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (1)

  • FDA 510(k) K221826 24 fields · synced Sep 18, 2026