Bd Phoenix Automated Microbiology System Tigecycline (0.25-16 Ug/Ml)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132909 FDA 510(k)
- FDA Product Code
- LON FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1645 FDA 510(k)
- Regulation Number
- 866.1645 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Phoenix Automated Microbiology System Tigecycline (0.25–16 µg/mL) is an automated antimicrobial susceptibility testing system designed for in vitro identification and quantitative determination of bacterial susceptibility. It measures minimal inhibitory concentrations (MICs) of tigecycline against most Gram-negative aerobic and facultative anaerobic bacteria, including those in the Enterobacteriaceae and Non-Enterobacteriaceae families.
This system is intended for use in clinical microbiology laboratories and operates as a reusable, automated platform for rapid antimicrobial testing. Supplied as part of the BD Phoenix system, it adheres to FDA regulatory requirements under 510(k) clearance (K132909) and falls under FDA classification II (866.1645). No sterility or single-use specifications are indicated, and MRI safety is not applicable to this device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bd Phoenix Automated Microbiology System Tigecycline (0.25-16 Ug/Ml ..., PDF BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE… - FDA.report, Bd Phoenix Automated Microbiology System Tigecycline (0.25-16 Ug/Ml)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132909 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K132909 24 fields · synced Sep 18, 2026