BD FocalPoint

FDA UDI

Class III (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name: BD FocalPoint FDA UDI
Generic Name: Cell morphology analyser IVD, manual FDA UDI
Device Name: BD FocalPoint™ Slide Profiler is an automated cytology screening device that classifies slides using a high speed video microscope, digital camera, and image interpretation software. Slide results data are presented through reports from the BD FocalPoint Workstation Computer. BD FocalPoint instrument with digital imaging system. FDA UDI
Model / Reference: 491086 FDA UDI
Description: BD FocalPoint™ Slide Profiler is an automated cytology screening device that classifies slides using a high speed video microscope, digital camera, and image interpretation software. Slide results data are presented through reports from the BD FocalPoint Workstation Computer. BD FocalPoint instrument with digital imaging system. FDA UDI

Identifiers

Catalog Number: 491086 FDA UDI
Primary DI / UDI-DI: 00382904910860 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: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 33.5 Inch FDA UDI
Width — 33.5 Inch FDA UDI
Length — 29 Inch FDA UDI

BD FocalPoint by Becton Dickinson And Company — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P950009 also covers:

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 8fbd3056-036d-4ddb-86d3-7150ecb83cd9 39 fields · synced Jun 8, 2026