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Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5

by Oxoid Limited (Part of Thermo Fisher Scientific)

510(k) K231806

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK231806 Date22 Mar 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JTN
Device Class
Class II
Regulation
21 CFR Part 866.1620
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a susceptibility test disc, antimicrobial, used for determining the susceptibility of microorganisms to rezafungin. It contains 5 micrograms of rezafungin and is designed for use in laboratory settings to assess antimicrobial effectiveness.

It is supplied as a diagnostic device for in vitro use, with authorization under FDA 510(k) clearance (K231806). The device is intended for use in microbiology laboratories and is regulated as a Class II medical device under regulation number 866.1620.

Other devices from Oxoid Limited (Part of Thermo Fisher Scientific)

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 used for?

    The device is a susceptibility test disc used to determine the susceptibility of microorganisms to rezafungin by measuring antimicrobial effectiveness in laboratory settings, specifically for in vitro testing in microbiology labs to assess how well the antifungal agent inhibits microbial growth.

  • How is the Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 supplied and what is its format?

    It is supplied as a diagnostic device containing 5 micrograms of rezafungin per disc, designed for in vitro use in microbiology laboratories, and provided in a standard disc format suitable for antimicrobial susceptibility testing procedures like disk diffusion.

  • Is the Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 reusable or single-use, and what are its storage requirements?

    The device is intended for single-use in laboratory testing to ensure accuracy and prevent cross-contamination; while specific storage conditions are not detailed in the provided data, such discs typically require refrigerated storage to maintain antibiotic potency until use, as is standard for antimicrobial susceptibility test discs.