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Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL

by Liofilchem S.r.l.

510(k) K173307

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 NumberK173307 Date19 Dec 2017ClearedStatusActive

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  • Withdrawn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, 21 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 device is a Manual Antimicrobial Susceptibility Test System, specifically a MIC Test Strip (MTS) for Meropenem/vaborbactam. It is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria.

It is supplied in packs of 10 strips and used to determine the Minimum Inhibitory Concentration (MIC) of antimicrobial agents against microorganisms to indicate appropriate patient treatment and identify resistance patterns. The device has FDA 510(k) clearance under K173307 and is classified as a Class II medical device under regulation number 866.1640.

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Questions

AI-generated answers, 21 Sep 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 Liofilchem MIC Test Strip used for?

    The Liofilchem MIC Test Strip is a manual antimicrobial susceptibility test system used to determine the Minimum Inhibitory Concentration (MIC) of Meropenem/vaborbactam against bacteria in vitro, helping to guide appropriate patient treatment and identify resistance patterns.

  • How is the Liofilchem MIC Test Strip supplied and what is its format?

    The device is supplied in packs of 10 strips and is designed as a quantitative MIC Test Strip (MTS) for use in laboratory settings to measure antimicrobial susceptibility of microorganisms.

  • Is the Liofilchem MIC Test Strip intended for single use or reuse?

    As a manual antimicrobial susceptibility test system in strip format, the Liofilchem MIC Test Strip is intended for single-use application per test to ensure accurate and uncontaminated results.