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Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

by Liofilchem S.r.l.

510(k) K153569

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 NumberK153569 Date22 Jun 2016ClearedStatusActive

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  • Withdrawn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
JWY
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

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

The Liofilchem MIC Test Strip (MTS) is a manual antimicrobial susceptibility test system designed to determine the minimum inhibitory concentration (MIC) of dalbavancin against bacterial isolates. Classified as a gradient diffusion test, it provides quantitative measurement of antibiotic efficacy by assessing microbial growth inhibition across a predefined concentration gradient of dalbavancin (0.002–32 µg/ml) on a paper strip. This aids in guiding targeted antimicrobial therapy and resistance surveillance in clinical microbiology settings.

The device is supplied as a single-use, non-sterile test strip intended for in vitro use in microbiology laboratories. It requires manual handling, including preparation of bacterial inoculum and application to agar plates, followed by incubation and measurement of inhibition zones. Compliance with FDA 510(k) clearance (K153569) ensures adherence to regulatory standards for antimicrobial susceptibility testing. Storage conditions and shelf life are specified in accompanying documentation, with no MRI compatibility or reusable components indicated.

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