MicroScan MicroStrep Plus Panel Azithromycin

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K062585 ↗

FDA Product Code

LRG

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the MicroScan MicroStrep Plus Panel Azithromycin used for?

  It is an instrument designed for auto reader and interpretation of overnight susceptibility systems, supporting antimicrobial susceptibility analysis in microbiology testing within clinical laboratory settings.

• How is the MicroScan MicroStrep Plus Panel Azithromycin supplied and used?

  It is supplied as a panel intended for use with the MicroScan WalkAway plus Microbiology System, enabling automated reading and interpretation of susceptibility results in clinical laboratories.

• Is the MicroScan MicroStrep Plus Panel Azithromycin a single-use or reusable device?

  The device data does not specify whether the panel is single-use or reusable; it is described as an instrument panel for use with the MicroScan WalkAway plus system, but no details on reusability are provided in the authorization or description.