BD Phoenix Automated Microbiology System - Ampicillin-Sulbactam (GN) 0.5/0.25-32/16UG/ML

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

510(k) Number

K043389 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• Bd Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 Ug/Ml

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• What is the primary function of the BD Phoenix Automated Microbiology System?

  This system is designed to perform automated, short incubation antimicrobial susceptibility testing. It specifically facilitates testing for the antibiotic combination of ampicillin-sulbactam in microbiology laboratory settings.

• What is the regulatory status of this device?

  The BD Phoenix Automated Microbiology System has received FDA 510(k) clearance. It is classified as a class 2 medical device under regulation number 866.1645, which pertains to automated antimicrobial susceptibility test systems.

• What concentration range does this specific test cover?

  This specific configuration of the BD Phoenix system is calibrated for ampicillin-sulbactam testing within the concentration range of 0.5/0.25 to 32/16 ug/mL.