Identity
- Trade Name
- BD PhoenixSpec EUDAMEDBD PhoenixSpec™ Calibrator 0.25 McFarland FDA UDI
- Generic Name
- Microorganism-density nephelometer IVD FDA UDI
- Device Name
- BD PhoenixSpec™ Calibrator 0.25 McFarland EUDAMEDFDA UDI
- Model / Reference
- 441355 EUDAMEDFDA UDI
- Description
- BD PhoenixSpec™ Calibrator 0.25 McFarland FDA UDI
Identifiers
- Catalog Number
- 441355 FDA UDI
- Primary DI / UDI-DI
- 00382904413552 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290MBBSPWMT9Q EUDAMED
- FDA Product Code
- JQX FDA UDI
- EMDN Code
- W01040699 CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER EUDAMED
- GMDN Term
- Microorganism-density nephelometer IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2700 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
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
Category: Multiple bacteria species culture isolate identification control IVD, kit
BD PhoenixSpec by Becton, Dickinson and Company — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 038290MBBSPWMT9Q | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
- EUDAMED SRN
- US-MF-000018910
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (2)
- EUDAMED 461ab4fa-dbe1-46da-8c17-4616fa68b53d 61 fields · synced Jun 9, 2026
- FDA UDI d4140ffa-045f-4ce5-bde4-f9baed42a94a 36 fields · synced May 30, 2026