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MIC Panels

by American Micro Scan PMA

Active United States

PMA N62160

Overview

MIC Panels are antimicrobial susceptibility test panels designed for microbiological analysis. These devices facilitate the determination of minimum inhibitory concentrations (MICs) of antimicrobial agents against bacterial isolates, aiding in the selection of appropriate antibiotic therapies.

Supplied as single-use diagnostic aids, MIC Panels are intended for use in clinical microbiology laboratories. They are regulated under FDA Premarket Approval (PMA) as Class II devices under regulation number 866.1640, with product code LTT. Sterility and proper storage conditions are critical for maintaining their integrity and performance.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberN62160 Date10 Feb 1981ApprovedStatusActive

Coverage

1 jurisdiction

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

United States — FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

PMA

Generic Name
Panels, test, susceptibility, antimicrobial
PMA Number
FDA Product Code
LTT
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
APPR Approved
PMA Supplement
S004

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Questions

  • What is the purpose of MIC Panels?

    MIC Panels are antimicrobial susceptibility test panels designed for microbiological analysis to determine minimum inhibitory concentrations of antimicrobial agents against bacterial isolates, helping select appropriate antibiotic therapies.

  • How are MIC Panels supplied?

    MIC Panels are supplied as single-use diagnostic aids intended for use in clinical microbiology laboratories, with sterility being critical for maintaining their integrity and performance.

  • What is the regulatory classification of MIC Panels?

    MIC Panels are regulated under FDA Premarket Approval (PMA) as Class II devices under regulation number 866.1640, with product code LTT.

  • What are the proper storage conditions for MIC Panels?

    Proper storage conditions are critical for maintaining the integrity and performance of MIC Panels, though specific temperature requirements are not detailed in the provided information.