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BD FocalPoint™ GS Review Station

FDA UDI

Class III (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
BD FocalPoint™ GS Review Station FDA UDI
Generic Name
Cell morphology analyser IVD, manual FDA UDI
Device Name
BD FocalPoint™ GS Review Station Computer FDA UDI
Model / Reference
490189 FDA UDI
Description
BD FocalPoint™ GS Review Station Computer FDA UDI

Identifiers

Catalog Number
490189 FDA UDI
Primary DI / UDI-DI
00382904901899 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

Dimensions & Sizes

Size
Height — 33.2 Centimeter FDA UDI
Width — 55 Centimeter FDA UDI
Length — 59.2 Centimeter FDA UDI

Category: Cell morphology analyser IVD, manual

BD FocalPoint™ GS Review Station 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.

Cleared under the same submission

P950009 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Becton Dickinson And Company

Sources (1)

  • FDA UDI 46aa5b73-5556-483e-ad3d-15e069e7d18a 38 fields · synced Jun 1, 2026