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ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

by Biomerieux S.A.

510(k) K190154

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190154↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK190154 Date1 May 2019ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 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 ETEST Piperacillin/Tazobactam (P/T) is a manual antimicrobial susceptibility test system used for determining bacterial susceptibility to the antibiotic combination of piperacillin and tazobactam. Classified as a manual antimicrobial susceptibility test system, it adheres to microbiological standards for in vitro testing of microbial resistance, providing quantitative minimum inhibitory concentration (MIC) values ranging from 0.016/4 to 256/4 µg/mL.

This single-use, non-sterile test strip is intended for use in microbiology laboratories to evaluate bacterial isolates against piperacillin/tazobactam. Supplied as individual strips, it requires no special storage conditions beyond refrigeration (2–8°C) and is compatible with standard laboratory practices. Authorized under FDA 510(k) clearance and IVDR compliance, it is regulated under classification II (device class 2) for antimicrobial susceptibility testing in clinical microbiology settings.

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Questions

AI-generated answers, 18 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 ETEST Piperacillin/Tazobactam used for in a clinical setting?

    The ETEST Piperacillin/Tazobactam (P/T) is a manual antimicrobial susceptibility test system designed to determine bacterial susceptibility to the antibiotic combination of piperacillin and tazobactam. It provides quantitative minimum inhibitory concentration (MIC) values (ranging from 0.016/4 to 256/4 µg/mL) to help microbiology laboratories evaluate how bacteria respond to this specific antibiotic pairing, aiding in informed treatment decisions.

  • Are the ETEST Piperacillin/Tazobactam strips single-use or reusable, and what storage conditions are required?

    The ETEST Piperacillin/Tazobactam strips are single-use only and are non-sterile. They do not require special storage conditions beyond refrigeration, with a recommended temperature range of 2–8°C to maintain stability. This makes them compatible with standard laboratory refrigeration practices.

  • How is this device regulated, and what classification does it fall under?

    The ETEST Piperacillin/Tazobactam is regulated under FDA 510(k) clearance and complies with the In Vitro Diagnostic Regulation (IVDR). It is classified as a Class II (Device Class 2) medical device, specifically under the product code JWY for manual antimicrobial susceptibility test systems, ensuring it meets stringent microbiological standards for in vitro testing.

  • What MIC range does the ETEST Piperacillin/Tazobactam provide, and why is this important?

    The ETEST Piperacillin/Tazobactam provides MIC values spanning 0.016/4 to 256/4 µg/mL, allowing laboratories to precisely measure bacterial resistance or susceptibility to the antibiotic combination. This broad range ensures accurate differentiation between sensitive, intermediate, and resistant bacterial strains, which is critical for guiding appropriate antibiotic therapy and combating antimicrobial resistance.