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Terramycin Diagnostic Susceptibility Powder

by Pfizer Inc. PMA

Active United States

PMA N50009

Overview

This device is an antimicrobial susceptibility test powder, classified under the generic name ‘Susceptibility test powders, antimicrobial.’ It is designed for in vitro testing to determine bacterial pathogen susceptibility to Terramycin, aiding clinical microbiology diagnostics. The powder is formulated for precise antimicrobial susceptibility assessments in laboratory settings, adhering to microbiological standards.

The Terramycin Diagnostic Susceptibility Powder is supplied in vials and intended for single-use in clinical laboratories. It is regulated under FDA PMA (N50009) and falls under Product Code JTT, categorized within the microbiology specialty. No information regarding sterility, MRI safety, or reusable status is provided in the specifications. Storage and handling instructions are not detailed beyond standard laboratory practices for antimicrobial test powders.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberN50009 Date27 Feb 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 Terramycin Diagnostic Susceptibility Powder used for in a clinical setting?

    The Terramycin Diagnostic Susceptibility Powder is designed for in vitro testing to determine how susceptible bacterial pathogens are to Terramycin. This helps clinical microbiologists assess which antibiotics may effectively treat infections caused by specific bacteria, supporting informed treatment decisions in laboratory settings.

  • How is the Terramycin Diagnostic Susceptibility Powder supplied, and is it meant for single or repeated use?

    The powder is supplied in vials and is explicitly intended for single-use in clinical laboratories. Each vial is meant to be used once for antimicrobial susceptibility testing, ensuring accuracy and preventing cross-contamination.

  • What regulatory pathway does the Terramycin Diagnostic Susceptibility Powder follow, and how is it classified?

    The device follows the FDA PMA (Premarket Approval) pathway, with the approval number N50009. It is classified under Product Code JTT and falls under the broader category of Susceptibility Test Powders, Antimicrobial, regulated under FDA regulation 866.1640. This classification aligns with its use in microbiology diagnostics.

  • Are there any details provided about how to store or handle this product beyond standard lab practices?

    The provided specifications do not include specific storage or handling instructions beyond what is standard for antimicrobial susceptibility test powders in clinical laboratories. Users should follow general microbiological practices to maintain integrity, such as protecting from moisture and contamination until use.