Identity
- Trade Name
- BACTEC EUDAMEDBD BACTEC™ FX40 Instrument FDA UDI
- Generic Name
- Blood culture analyser IVD FDA UDI
- Device Name
- BD BACTEC™ FX40 Instrument EUDAMEDFDA UDI
- Model / Reference
- 442296 EUDAMEDFDA UDI
- Description
- BD BACTEC™ FX40 Instrument FDA UDI
Identifiers
- Catalog Number
- 442296 FDA UDI
- Primary DI / UDI-DI
- 00382904422967 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290WAUCLFLID2 EUDAMED
- 510(k) Number
- K915796 FDA UDI
- FDA Product Code
- MDB FDA UDI
- EMDN Code
- W02030201 AUTOMATED BLOOD CULTURE ANALYSERS EUDAMED
- GMDN Term
- Blood culture analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2560 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 39.1 Centimeter FDA UDIDepth — 58.5 Centimeter FDA UDIWidth — 67.5 Centimeter FDA UDI
Bactec 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 | 038290WAUCLFLID2 | 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 5c077da6-4036-4cec-9c45-900a323889a8 61 fields · synced Oct 6, 2026
- FDA UDI db329464-5afd-499e-aac4-09c611fd4e1d 38 fields · synced May 29, 2026