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Geopen Susceptibility Powder

by Pfizer Inc. PMA

Active United States

PMA N50413

Overview

The Geopen Susceptibility Powder is an antimicrobial susceptibility test powder, classified under the generic name ‘Susceptibility test powders, antimicrobial.’ This device consists of antimicrobial drug powders packaged in vials for in vitro testing of bacterial pathogens. It is designed to determine the effectiveness of therapeutic agents against specific bacteria, aiding clinical decision-making for bacterial disease treatment. The device falls under the product code JTT and is intended for use in microbiology settings.

This powder is supplied in sterile vials and is intended for single-use in clinical laboratories. It is regulated under FDA Premarket Approval (PMA) with approval number N50413, classified as a Class II device under 21 CFR 866.1640. The device is intended for use in microbiology applications and must be handled according to standard aseptic techniques. No additional regulatory status beyond the stated PMA is implied.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberN50413 Date10 Sep 1970DecidedStatusActive

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
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Generic Name
Susceptibility test powders, antimicrobial
FDA applicant
Pfizer, Inc.
PMA Number
FDA Product Code
JTT
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
APRL

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Questions

  • What is the Geopen Susceptibility Powder used for in a clinical setting?

    The Geopen Susceptibility Powder is designed for in vitro testing to determine how effective different antimicrobial drugs are against specific bacterial pathogens. This helps clinicians select the most appropriate treatment for bacterial infections by identifying which antibiotics will be most effective against the isolated bacteria.

  • Is the Geopen Susceptibility Powder intended for single-use or can it be reused?

    The Geopen Susceptibility Powder is explicitly intended for single-use in clinical laboratories. Each vial is sterile and meant to be used once, ensuring accurate and reliable test results while maintaining proper aseptic techniques.

  • How is the Geopen Susceptibility Powder supplied, and what precautions should be taken during handling?

    The powder is supplied in sterile vials, packaged for microbiology use. Since it is sterile and intended for single-use, it must be handled using standard aseptic techniques to prevent contamination and ensure accurate antimicrobial susceptibility testing results.

  • What regulatory pathway does the Geopen Susceptibility Powder follow, and what does this mean for its use?

    The Geopen Susceptibility Powder follows the FDA Premarket Approval (PMA) pathway, classified as a Class II device under 21 CFR 866.1640. This means it has undergone rigorous review to ensure safety and effectiveness for its intended use in microbiology settings, specifically for in vitro antimicrobial susceptibility testing.