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MIC Test Panels

by Microtech Medical Systems, Inc.

PMA N50487

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA N50487

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberN50487 Date22 Sep 1981ApprovedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
PMA Number
FDA Product Code
LON
Device Class
Class II
Regulation
21 CFR Part 866.1645
Advisory Committee
Microbiology
FDA Decision
APPR Approved
PMA Supplement
S010

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MIC Test Panels are an Automated Antimicrobial Susceptibility Test System designed for short incubation periods. This device is classified under the generic name ‘System, Test, Automated, Antimicrobial Susceptibility, Short Incubation’ and falls under the FDA’s Device Class 2 category, regulated under 21 CFR 866.1645. It is intended for microbiological testing to determine antimicrobial susceptibility of bacterial isolates.

These panels are supplied as single-use diagnostic aids for use in clinical microbiology laboratories. They are not intended for MRI use and must be stored according to manufacturer instructions to maintain sterility and performance. The device holds a Premarket Approval (PMA) from the FDA under PMA number N50487, with subsequent supplements (e.g., S010) addressing modifications or updates to the original submission. No additional regulatory status beyond the stated PMA is implied.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the MIC Test Panels?

    The MIC Test Panels are designed for microbiological testing to determine antimicrobial susceptibility of bacterial isolates, featuring an automated system with short incubation periods for clinical microbiology laboratories.

  • How are the MIC Test Panels supplied and can they be reused?

    These panels are supplied as single-use diagnostic aids and are not intended for reuse. They must be used according to manufacturer instructions to maintain sterility and performance.

  • What are the storage requirements for the MIC Test Panels?

    The panels must be stored according to manufacturer instructions to maintain sterility and performance, though specific storage conditions are not detailed in the provided information.

  • What regulatory status does the MIC Test Panels hold?

    The device holds a Premarket Approval (PMA) from the FDA under PMA number N50487, with subsequent supplements such as S010 addressing modifications or updates to the original submission.