Identity
- Trade Name
- BD™ FocalPoint™ Slide Profiler Refurbished FDA UDI
- Generic Name
- Cell morphology analyser IVD, manual FDA UDI
- Device Name
- Focal Point Digital Refurb 2 FDA UDI
- Model / Reference
- 491490 FDA UDI
- Description
- Focal Point Digital Refurb 2 FDA UDI
Identifiers
- Catalog Number
- 491490 FDA UDI
- Primary DI / UDI-DI
- 00382904914905 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
Yes
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 Refurbished by Becton Dickinson And Company — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cell morphology analyser IVD, manual.
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- BD FocalPoint — BECTON DICKINSON AND COMPANY · Class III
- BD FocalPoint — BECTON DICKINSON AND COMPANY · Class III
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 |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI bdeb2c3c-c896-4017-a223-ba4d7db97e06 36 fields · synced May 30, 2026