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K Number
K250789Device Name
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
Manufacturer
Thermo Fisher Scientific (Oxoid Ltd.)
Date Cleared
2025-06-12
(90 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
Thermo Fisher Scientific (Oxoid Ltd.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.
The Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is intended to determine susceptibility of Enterobacterales to Aztreonam/Avibactam, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 demonstrated acceptable performance to determine susceptibility to Aztreonam/Avibactam against the following microorganisms:
Enterobacterales (Citrobacter freundii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, and Proteus mirabilis)
Device Description
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
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