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MTS Eravacycline 0.002 - 32 µg/mL

by Liofilchem S.r.l.

510(k) K182557

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 NumberK182557 Date2 Nov 2018ClearedStatusActive

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  • Withdrawn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, 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.

This is a Manual Antimicrobial Susceptibility Test System device. It is an MIC Test Strip used for determining the Minimum Inhibitory Concentration of antimicrobial agents against microorganisms.

The device is supplied as individually packed strips, available in quantities of 10/pack, 30/pack, or 100/canister pack. It is made of special high-quality paper impregnated with a predefined concentration gradient of eravacycline across 15 two-fold dilutions ranging from 0.002 to 32 µg/mL. The product has FDA 510(k) clearance under K182557 and is classified as a Class II device.

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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 MTS Eravacycline 0.002 - 32 µg/mL used for?

    This device is a Manual Antimicrobial Susceptibility Test System used to determine the Minimum Inhibitory Concentration (MIC) of eravacycline against microorganisms. It employs a paper strip impregnated with a predefined concentration gradient to assess antimicrobial susceptibility in laboratory settings.

  • How is the MTS Eravacycline test strip supplied and packaged?

    The device is supplied as individually packed strips, available in quantities of 10 per pack, 30 per pack, or 100 per canister pack. Each strip contains a concentration gradient of eravacycline across 15 two-fold dilutions ranging from 0.002 to 32 µg/mL.

  • Is the MTS Eravacycline test strip sterile and intended for single use?

    The strips are supplied individually packed, which ensures sterility until opened, and are intended for single-use application in antimicrobial susceptibility testing. Reuse is not recommended as it could compromise test accuracy and sterility.