BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam - 8-32
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Phoenix EUDAMEDBD Phoenix™ YEAST ID FDA UDI
- Generic Name
- Yeast species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
- Device Name
- BD Phoenix™ YEAST ID EUDAMEDFDA UDIBD Phoenix™ NMIC-488 EUDAMED
- Model / Reference
- 448316 EUDAMEDFDA UDI449529 EUDAMED
- Description
- BD Phoenix™ YEAST ID FDA UDI
Identifiers
- Catalog Number
- 448316 FDA UDI
- Primary DI / UDI-DI
- 00382904483166 EUDAMEDFDA UDI30382904495290 EUDAMED
- Basic UDI-DI
- 038290LGZJOIHCEH EUDAMED038290JHJJQPLUAD EUDAMED
- Unit of Use DI
- 00382904495299 EUDAMED
- 510(k) Number
- K173523 FDA 510(k)
- FDA Product Code
- LON FDA 510(k)JXB FDA UDI
- EMDN Code
- W0104080107 GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED EUDAMEDW0104030403 IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED EUDAMED
- GMDN Term
- Yeast species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA 510(k)Class I FDA UDI
- Legislation / Framework
- 21 CFR Part 866.1645 FDA 510(k)
- Regulation Number
- 866.1645 FDA 510(k)866.2660 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8–32/8 µg/mL) is an automated antimicrobial susceptibility testing system designed for in vitro quantitative determination of minimal inhibitory concentrations (MICs). It evaluates susceptibility profiles of Gram-negative aerobic and facultative anaerobic bacteria, including Enterobacteriaceae and Non-Enterobacteriaceae, to meropenem-vaborbactam.
This system is intended for use in clinical microbiology laboratories and operates as a reusable, non-sterile device under IVDR and FDA 510(k) clearance (K173523). It requires no specific MRI safety considerations and is supplied as part of the broader BD Phoenix platform, adhering to regulatory standards for antimicrobial susceptibility testing. No additional sterility or single-use requirements are specified for this particular antimicrobial panel.
Frequently asked questions
What types of bacteria does the BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam panel test for susceptibility to meropenem-vaborbactam?
This panel is designed specifically for Gram-negative aerobic and facultative anaerobic bacteria, including both Enterobacteriaceae and Non-Enterobacteriaceae families. It quantifies minimal inhibitory concentrations (MICs) to evaluate how susceptible these bacteria are to meropenem-vaborbactam, helping guide targeted antibiotic therapy in clinical settings.
Is the BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam panel intended for single-use or reusable in a clinical lab?
The system itself is reusable and non-sterile, as explicitly stated in the regulatory documentation. The antimicrobial susceptibility testing panel is part of the broader BD Phoenix platform, which operates under these conditions. No single-use requirements are specified for this particular panel.
What regulatory pathways has the BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam panel followed for approval?
The panel has been cleared through both the FDA’s 510(k) pathway (with clearance number K173523) and the In Vitro Diagnostic Regulation (IVDR) in the European Union. The submission was reviewed by the FDA’s Microbiology (MI) Advisory Committee and determined to be substantially equivalent to a predicate device.
How is the BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam panel supplied, and what are its key concentration ranges for testing?
The panel is supplied as part of the BD Phoenix Automated Microbiology System, which is a reusable platform for antimicrobial susceptibility testing. The specific concentration range for meropenem-vaborbactam testing is 0.125/8 to 32/8 µg/mL, allowing for quantitative MIC determination across this spectrum to assess bacterial susceptibility.
Are there any special storage requirements for the BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam panel?
The documentation does not specify unique storage requirements beyond those applicable to the broader BD Phoenix platform. Since the system is reusable and non-sterile, standard laboratory conditions for automated microbiology systems should be followed, including protection from contamination and environmental factors that could compromise performance.
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 - GN Meropenem-vaborbactam (0. ..., BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0. ..., Becton Dickinson – Wikipedia, BD Phoenix Automated Microbiology Syste... (K173523) - FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173523 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (4)
- FDA 510(k) K173523 24 fields · synced Sep 18, 2026
- FDA UDI b166e317-7b57-497e-be48-3f02bb5c6aec 36 fields · synced May 30, 2026
- EUDAMED 567e36e0-1d39-43d6-b786-f93d8e2394fe 61 fields · synced Jul 16, 2026
- EUDAMED 71fe6bc4-acc7-405f-8ccd-b251aadf45f2 61 fields · synced Jul 24, 2026