Identity
- Trade Name
- BD PhoenixSpec EUDAMEDBD PhoenixSpec™ Calibrator 0.50 McFarland FDA UDI
- Generic Name
- Microorganism-density nephelometer IVD FDA UDI
- Device Name
- BD PhoenixSpec™ Calibrator 0.50 McFarland EUDAMEDFDA UDI
- Model / Reference
- 441356 EUDAMEDFDA UDI
- Description
- BD PhoenixSpec™ Calibrator 0.50 McFarland FDA UDI
Identifiers
- Catalog Number
- 441356 FDA UDI
- Primary DI / UDI-DI
- 00382904413569 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290MDEHOCIX4R 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
BD PhoenixSpec by Becton, Dickinson and Company — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 038290MDEHOCIX4R | 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 d5d7afd4-b058-4e5d-b1bc-7408bfecae0e 61 fields · synced Oct 6, 2026
- FDA UDI b6cc5568-4448-4cb2-9bd1-79c91b3381a2 36 fields · synced May 30, 2026