Bacitracin Diagnostic Susceptibility Powder
by Pfizer Inc. PMA
Active
PMA N50016
Overview
This device is an antimicrobial susceptibility test powder, classified under the nomenclature for susceptibility test powders. It is used to determine bacterial susceptibility to bacitracin, aiding in the selection of appropriate antimicrobial therapy by evaluating microbial resistance patterns in clinical microbiology settings.
The Bacitracin Diagnostic Susceptibility Powder is supplied as a sterile, single-use diagnostic reagent for in vitro microbiological testing. It is intended for use in microbiology laboratories and adheres to regulatory standards under FDA Premarket Approval (PMA). The product is packaged in sterile containers and must be stored according to manufacturer guidelines to maintain efficacy.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberN50016 | Date24 Nov 1969 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 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
Other devices from Pfizer Inc.
Questions
What clinical setting or laboratory is this Bacitracin Diagnostic Susceptibility Powder designed for use in?
This powder is specifically designed for use in microbiology laboratories to aid in determining bacterial susceptibility to bacitracin. It helps clinicians select appropriate antimicrobial therapy by evaluating how bacteria respond to the antibiotic, ensuring tailored treatment decisions based on resistance patterns.
Is this Bacitracin Diagnostic Susceptibility Powder meant for single-use or repeated use, and why?
The Bacitracin Diagnostic Susceptibility Powder is intended for single-use only because it is classified as a sterile diagnostic reagent. Reusing it could compromise sterility, accuracy, or reliability of susceptibility testing results, which are critical for patient care.
How should this product be stored to ensure it remains effective for testing?
While the exact storage instructions are not detailed here, the product is described as a sterile diagnostic reagent, so it must be stored according to the manufacturer’s guidelines—typically in a clean, dry environment away from extreme temperatures or contamination—to preserve sterility and potency until use.
What regulatory pathway was followed for this device’s approval, and what does that mean for its use?
This device was approved through the FDA Premarket Approval (PMA) pathway, indicated by the PMA number (N50016). This means it underwent rigorous scientific review to ensure safety and effectiveness for its intended use in antimicrobial susceptibility testing, providing confidence in its reliability for clinical microbiology applications.