3M Brand Microbial Profile System

No FDA recalls on record, checked 22 Oct 2026.

Trade Name

Flow Mic System

Generic Name

SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

PMA Number

N50538 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

APRL

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  Class I

  FDA 510(k) K771955 Active Cleared 22 Nov 1977

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  Class I

  FDA 510(k) K770807 Active Cleared 20 May 1977

• Enteric-Tek

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  FDA 510(k) K792058 Active Cleared 11 Jan 1980

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  FDA 510(k) K862066 Active Cleared 5 Jun 1986

• Neigon Jembec Plate with Anixomycin

  Class II

  FDA 510(k) K760693 Active Cleared 7 Oct 1976

• Gentamicin Sulfate Solution (50mg Gentamicin)

  Class I

  FDA 510(k) K861823 Active Cleared 20 May 1986

See all devices from Flow Laboratories, Inc. →

• What is the primary purpose of the 3M Brand Microbial Profile System in a clinical setting?

  The 3M Brand Microbial Profile System is designed for automated antimicrobial susceptibility testing in microbiology laboratories. It helps identify bacterial resistance patterns quickly, enabling faster targeted antimicrobial therapy and improved infection control by reducing the time required for traditional testing methods.

• Is the 3M Brand Microbial Profile System intended for single-use or reusable applications?

  The system is explicitly described as a reusable device. It requires proper calibration and maintenance as outlined by the manufacturer to ensure accurate and reliable performance over time.

• What type of regulatory authorization does the 3M Brand Microbial Profile System hold, and how was it classified?

  The device holds FDA_PMA authorization, which was granted under regulation number 866.1645. It is classified as a Class II medical device, as indicated by the OpenFDA data (device_class=2). The PMA number assigned is N50538.

• Can this system be used in environments with MRI equipment, or does it have any restrictions?

  The system is explicitly stated to operate within standard laboratory environments and is not intended for use in MRI settings. This restriction is likely due to potential electromagnetic interference or safety concerns in magnetic resonance environments.

• What kind of maintenance or calibration is required for the 3M Brand Microbial Profile System?

  Since the system is reusable, it requires proper calibration and maintenance as specified by the manufacturer (Flow Laboratories, Inc.). Regular upkeep ensures accurate antimicrobial susceptibility testing results, which is critical for clinical decision-making in microbiology.