Oleandomycin Phosphate Susceptibility Powder
by Pfizer Inc. PMA
Active
PMA N50062
Overview
The Oleandomycin Phosphate Susceptibility Powder is a Susceptibility Test Powder, Antimicrobial (per FDA nomenclature), designed for use in microbiological testing to determine bacterial susceptibility to oleandomycin phosphate. This powder is intended for in vitro diagnostic use, enabling laboratories to assess whether bacterial isolates are resistant or susceptible to the antibiotic, aiding in appropriate antimicrobial therapy selection.
This powder is supplied as a sterile, single-use diagnostic reagent for microbiological laboratories. It is classified under FDA device class II (866.1640) and is regulated under the FDA_PMA authorization (PMA Number: N50062). Storage conditions and handling must comply with standard microbiological practices to maintain sterility and accuracy of susceptibility testing results.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberN50062 | 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- Withdrawn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 is the Oleandomycin Phosphate Susceptibility Powder used for in a clinical setting?
This powder is specifically designed for in vitro diagnostic use in microbiological laboratories. It helps determine whether bacterial isolates are resistant or susceptible to oleandomycin phosphate, which assists clinicians in selecting the most appropriate antibiotic therapy for patients.
Is the Oleandomycin Phosphate Susceptibility Powder intended for single-use or repeated use?
The powder is supplied as a sterile, single-use diagnostic reagent. This ensures accuracy and reliability in susceptibility testing, as reuse could compromise sterility and test integrity.
How should the Oleandomycin Phosphate Susceptibility Powder be stored to maintain its effectiveness?
Storage must follow standard microbiological practices to preserve sterility and ensure accurate susceptibility testing results. While exact conditions aren’t detailed here, adherence to general laboratory protocols for antimicrobial susceptibility powders is recommended.
What regulatory pathway does the Oleandomycin Phosphate Susceptibility Powder follow?
The product is regulated under the FDA’s Premarket Approval (PMA) pathway, with the assigned PMA number N50062. It falls under FDA device class II (product code JTT), indicating it requires a higher level of scrutiny than class I but not as stringent as class III.
What type of laboratory would typically use the Oleandomycin Phosphate Susceptibility Powder?
This powder is intended for microbiology laboratories that perform antimicrobial susceptibility testing. It aids in identifying bacterial resistance patterns to oleandomycin phosphate, which is critical for infectious disease management and antibiotic stewardship programs.