BD PrepStain Slide Processor

FDA UDI

Class III (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name: BD PrepStain Slide Processor FDA UDI
Generic Name: Microscope slide maker/stainer IVD FDA UDI
Device Name: BD PrepStain® Slide Processor transfers cell samples from the specimen tubes to settling chambers mounted to microscope slides. The instrument then automatically stains and rinses each slide FDA UDI
Model / Reference: 490100 FDA UDI
Description: BD PrepStain® Slide Processor transfers cell samples from the specimen tubes to settling chambers mounted to microscope slides. The instrument then automatically stains and rinses each slide FDA UDI

Identifiers

Catalog Number: 490100 FDA UDI
Primary DI / UDI-DI: 00382904901004 FDA UDI
PMA Number: P970018 FDA UDI
FDA Product Code: MKQ FDA UDI
GMDN Term: Microscope slide maker/stainer IVD FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Depth — 25 Inch FDA UDI
Width — 40 Inch FDA UDI
Height — 34 Inch FDA UDI

Category: Microscope slide maker/stainer IVD

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

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Also classified as Microscope slide maker/stainer IVD.

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Tissue-Tek Prisma® Plus — Sakura Finetek USA, Inc · Class I
ADVIA Autoslide® Slide Maker Stainer — Siemens Healthcare Diagnostics · Class I
ABX SPS EVOLUTION — Horiba Abx · Class I
ABX SPS EVOLUTION — Horiba Abx · Class I

Cleared under the same submission

P970018 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 9c631f06-2a8f-4a18-88fd-5faf59b41e9d 38 fields · synced May 30, 2026