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Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50

by Thermo Fisher Scientific (Oxoid Ltd.)

510(k) K250789

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) K250789↗

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 NumberK250789 Date12 Jun 2025ClearedStatusActive
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  • Withdrawn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
JTN
Device Class
Class II
Regulation
21 CFR Part 866.1620
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 Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is an antimicrobial susceptibility test disc used for determining bacterial sensitivity to the antibiotic combination of aztreonam and avibactam. This disc is classified under susceptibility test discs and is designed for microbiological testing in clinical and research settings to aid in identifying effective antimicrobial therapies for bacterial infections.

The disc is supplied as a single-use item for in vitro diagnostic use, adhering to IVDR and FDA 510(k) regulatory standards. It is intended for use in microbiology laboratories, where it is applied to inoculated agar plates to assess bacterial growth inhibition zones. Sterility and proper storage conditions are critical to maintain accuracy; the device is classified as Class II under FDA regulations and is authorized for use in microbiological susceptibility testing. The product code JTN and registration numbers (e.g., 8020667) further identify its regulatory compliance.

Other devices from Thermo Fisher Scientific (Oxoid Ltd.)

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 clinical setting is the Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 intended for use in, and how does it help in patient care?

    The Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is designed exclusively for microbiology laboratories to perform antimicrobial susceptibility testing. It aids in patient care by helping determine whether bacterial infections are sensitive or resistant to the antibiotic combination of aztreonam and avibactam. This information guides clinicians in selecting the most effective antimicrobial therapy, reducing trial-and-error prescribing and improving treatment outcomes for bacterial infections.

  • Is the Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 a single-use item, and if so, why is this important?

    Yes, the Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is a single-use item. This is critical because antimicrobial susceptibility testing requires sterile conditions to ensure accurate and reliable results. Reusing the disc could compromise sterility, leading to inaccurate inhibition zone measurements and potentially misleading treatment decisions.

  • What regulatory pathways does the Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 follow, and what does this mean for its use?

    The disc follows both FDA 510(k) clearance and In Vitro Diagnostic Regulation (IVDR) authorization pathways. This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device under FDA standards and compliance with EU IVDR requirements. Clinicians and laboratories can rely on its regulatory clearance as evidence of its safety, performance, and suitability for antimicrobial susceptibility testing in clinical and research settings.

  • How should the Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 be stored to maintain its integrity and accuracy?

    The disc must be stored under conditions that preserve sterility and prevent degradation, as specified by the manufacturer. While exact storage instructions are not detailed here, typical antimicrobial susceptibility test discs require protection from moisture, extreme temperatures, and light. Laboratories should follow the manufacturer’s guidelines (available in the product documentation) to ensure the disc remains effective for accurate bacterial sensitivity testing.

  • What does the product code JTN and the registration number (e.g., 8020667) indicate about this device’s regulatory status?

    The product code JTN and registration numbers (such as 8020667) are administrative identifiers used in regulatory databases to track submissions and compliance. They do not describe the device’s intended clinical use but confirm its classification under FDA 510(k) clearance and IVDR authorization. These codes help ensure traceability and compliance with global regulatory requirements for antimicrobial susceptibility test discs.