Autobac Mic Test System

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Mic Test System

Generic Name

SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

PMA Number

N50524 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

APPR Approved

PMA Supplement

S004

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See all devices from Organon Teknika Corp. →

• What is the Autobac Mic Test System used for in a clinical setting?

  The Autobac Mic Test System is an automated device designed specifically for microbiology laboratories to perform short-incubation antimicrobial susceptibility tests. It helps determine bacterial resistance patterns, which aids clinicians in selecting the most effective antibiotic therapy for treating infectious diseases.

• Is the Autobac Mic Test System a single-use or reusable device, and how should it be maintained?

  The Autobac Mic Test System is a reusable laboratory instrument. To ensure accurate and reliable test results, it requires proper calibration and maintenance as outlined in the manufacturer’s operational manual. Sterile conditions must be maintained during operation.

• What regulatory pathway does the Autobac Mic Test System follow, and what does this mean for its use?

  The Autobac Mic Test System holds a Premarket Approval (PMA) designation from the FDA, with PMA number N50524. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use in clinical microbiology settings, specifically for automated antimicrobial susceptibility testing.

• How should the Autobac Mic Test System be stored, and are there any special handling requirements?

  The Autobac Mic Test System must be stored and handled according to the manufacturer’s guidelines to preserve its accuracy and reliability. While the device itself is reusable, any consumables or test media used with it may have their own storage instructions, which should be followed to maintain optimal performance.