Streptomycin Suefate Diagnostic Susceptibility Pow
by Pfizer Inc. PMA
Active
PMA N50036
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberN50036 | Date24 Nov 1969 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 18 Sep 2026
This device is an antimicrobial susceptibility test powder, classified under the generic name Susceptibility test powders, antimicrobial. It is used to determine the sensitivity of bacterial isolates to streptomycin sulfate, aiding in the selection of appropriate antimicrobial therapy by identifying effective antibiotics for treating infections.
The Streptomycin Sulfate Diagnostic Susceptibility Powder is supplied as a sterile, single-use diagnostic reagent for in vitro microbiological testing. It is intended for use in clinical microbiology laboratories and adheres to regulatory standards under FDA_PMA authorization (PMA Number: N50036). Storage and handling follow standard microbiological practices to maintain sterility and efficacy, with no MRI safety considerations applicable.
Other devices from Pfizer Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary clinical purpose of the Streptomycin Sulfate Diagnostic Susceptibility Powder, and how does it help in patient care?
The Streptomycin Sulfate Diagnostic Susceptibility Powder is designed to test how sensitive bacterial isolates are to streptomycin sulfate in a laboratory setting. By identifying whether bacteria are resistant or susceptible to this antibiotic, clinicians can tailor antimicrobial therapy more effectively, reducing the risk of ineffective treatments or unnecessary antibiotic use.
Is this product intended for single-use only, and if so, why is that important for clinical laboratories?
Yes, the Streptomycin Sulfate Diagnostic Susceptibility Powder is supplied as a sterile, single-use diagnostic reagent. Single-use ensures sterility is maintained between tests, preventing cross-contamination and preserving the accuracy of susceptibility results—critical for reliable patient diagnosis and treatment decisions.
How should this product be stored, and what precautions should laboratories take to maintain its integrity?
Storage follows standard microbiological practices to preserve sterility and efficacy. While specific conditions aren’t detailed, laboratories should adhere to manufacturer guidelines (likely refrigeration or room temperature with protection from moisture/light) to prevent degradation. Proper handling minimizes contamination risks, ensuring accurate test outcomes for bacterial susceptibility.
What regulatory pathway does this device follow, and how does that affect its use in clinical settings?
This product is authorized under FDA_PMA (Premarket Approval), with PMA Number N50036, indicating it underwent rigorous review by the FDA’s Microbiology Devices Panel (MI). Clinicians can rely on its compliance with FDA standards, ensuring validated performance for antimicrobial susceptibility testing in clinical microbiology labs.