Identity
- Trade Name
- BD ProbeTec™ ET Instrument, U.S. FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Device Name
- BD ProbeTec™ ET Instrument, U.S. FDA UDI
- Model / Reference
- 440478 FDA UDI
- Description
- BD ProbeTec™ ET Instrument, U.S. FDA UDI
Identifiers
- Catalog Number
- 440478 FDA UDI
- Primary DI / UDI-DI
- 00382904404789 FDA UDI
- FDA Product Code
- LSL FDA UDI
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3390 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 28.5 Inch FDA UDIHeight — 21.5 Inch FDA UDIDepth — 28.5 Inch FDA UDI
BD ProbeTec™ ET Instrument, U.S. by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI ebc4636b-a731-4bc8-8a69-c1de70997267 38 fields · synced May 30, 2026