Vibramycin Diag. Susceptibility Powder (Doxycyclin
by Pfizer Inc.
PMA N50100
Active
Valid until
No expiry
FDA recalls
None foundDocuments
PMA N50100
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberN50100 | Date4 Sep 1969 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
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, 20 Sep 2026
This device is a Susceptibility Test Powder, Antimicrobial (generic name), designed for use in microbiology to determine the susceptibility of bacterial isolates to doxycycline. It falls under the FDA’s classification of Class II devices (device class 2) and is intended for in vitro diagnostic testing to assess antimicrobial efficacy against specific pathogens. The powder is formulated to facilitate standardized testing procedures in clinical microbiology laboratories.
The Vibramycin Diagnostic Susceptibility Powder (Doxycycline) is supplied as a single-use diagnostic reagent for laboratory use, with no indication of sterility requirements in the submitted data. It is assigned the product code JTT under FDA regulation 866.1640 and was authorized via a Premarket Approval (PMA) (PMA number N50100), filed under the Microbiology advisory committee (MI) in 1969. Storage conditions, MRI safety, or reusable components are not specified in the regulatory records.
Other devices from Pfizer Inc.
Questions
AI-generated answers, 20 Sep 2026
What is the Vibramycin Diagnostic Susceptibility Powder (Doxycycline) used for in a clinical setting?
This product is specifically designed for in vitro diagnostic testing in microbiology laboratories. It helps determine whether bacterial isolates are susceptible or resistant to doxycycline, allowing clinicians to make informed decisions about antibiotic treatment. The results guide whether doxycycline may be an effective option for infections caused by the tested bacteria.
How is the Vibramycin Diagnostic Susceptibility Powder (Doxycycline) supplied, and is it meant for single-use?
The powder is supplied as a single-use diagnostic reagent, meaning each vial or packet is intended for one testing procedure. This ensures accuracy and consistency in susceptibility testing, as reuse could compromise the integrity of the results. The packaging is optimized for laboratory use, where standardized testing is critical.
What regulatory pathway was followed for the approval of this device, and what does that mean for its use?
The Vibramycin Diagnostic Susceptibility Powder (Doxycycline) was authorized through the FDA’s Premarket Approval (PMA) process, specifically under PMA number N50100. This pathway is typically used for higher-risk devices, and the approval indicates that the product has undergone rigorous review by the Microbiology (MI) advisory committee to ensure its safety and effectiveness for determining bacterial susceptibility to doxycycline in clinical settings.
Are there different sizes or models available for this product, and how should it be stored?
The provided data does not specify multiple sizes or models for the Vibramycin Diagnostic Susceptibility Powder (Doxycycline), implying it is likely supplied in a standardized form for general laboratory use. Storage conditions are not detailed in the regulatory records, so it’s best to follow the manufacturer’s instructions (Pfizer Inc.) for optimal shelf life and performance, typically involving protection from moisture and extreme temperatures.