Identity
- Trade Name
- BD FocalPoint Slide Profiler FDA UDI
- Generic Name
- Cell morphology analyser IVD, manual FDA UDI
- Device Name
- BD FocalPoint Slide Profiler (RoHS, Universal Voltage) FDA UDI
- Model / Reference
- 491464 FDA UDI
- Description
- BD FocalPoint Slide Profiler (RoHS, Universal Voltage) FDA UDI
Identifiers
- Catalog Number
- 491464 FDA UDI
- Primary DI / UDI-DI
- 00382904914646 FDA UDI
- PMA Number
- P950009 FDA UDI
- FDA Product Code
- MNM FDA UDI
- GMDN Term
- Cell morphology analyser IVD, manual FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cell morphology analyser IVD, manual
BD FocalPoint Slide Profiler by Becton Dickinson And Company — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cell morphology analyser IVD, manual.
- BD FocalPoint™ Slide Profiler Refurbished — BECTON DICKINSON AND COMPANY · Class III
- BD FocalPoint™ GS Review Station — BECTON DICKINSON AND COMPANY · Class III
- BD™ FocalPoint™ Slide Profiler Refurbished — BECTON DICKINSON AND COMPANY · Class III
- BD FocalPoint — BECTON DICKINSON AND COMPANY · Class III
- BD FocalPoint — BECTON DICKINSON AND COMPANY · Class III
Cleared under the same submission
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 839a9021-0200-47d5-918d-c36b3b20763d 37 fields · synced May 31, 2026