Identity
- Trade Name
- PREPSTAIN EUDAMEDBD PrepStain Slide Processor FDA UDIBD PrepStain™ Non-GYN Test Kit FDA UDI
- Generic Name
- Microscope slide maker/stainer IVD FDA UDIGeneral specimen microscopy slide IVD, single-use FDA UDI
- Device Name
- BD PrepStain™ Non-GYN Test Kit EUDAMEDFDA UDIPrepStain® Slide Processor (Refurb) FDA UDI
- Model / Reference
- 491303 EUDAMEDFDA UDI490407 FDA UDI
- Description
- PrepStain® Slide Processor (Refurb) FDA UDIBD PrepStain™ Non-GYN Test Kit FDA UDI
Identifiers
- Catalog Number
- 490407 FDA UDI491303 FDA UDI
- Primary DI / UDI-DI
- 00382904913038 EUDAMEDFDA UDI00382904904074 FDA UDI
- Basic UDI-DI
- 038290EOAUUUTCCJ EUDAMED
- PMA Number
- P970018 FDA UDI
- FDA Product Code
- MKQ FDA UDIKEW FDA UDI
- EMDN Code
- W0202050385 LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES EUDAMED
- GMDN Term
- Microscope slide maker/stainer IVD FDA UDIGeneral specimen microscopy slide IVD, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass III FDA UDIClass I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDIIn Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDIFDA UDI
Lot / Batch Number
No
FDA UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Depth — 25 Inch FDA UDIWidth — 40 Inch FDA UDIHeight — 34 Inch FDA UDI
BD PrepStain Slide Processor by Becton Dickinson And Company — Class III — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
P970018 also covers:
- BD Density Reagent (480 ml) — BECTON DICKINSON AND COMPANY
- BD PrepMate™ Automated Accessory — BECTON DICKINSON AND COMPANY
- BD PrepMate™ Automated Accessory — BECTON DICKINSON AND COMPANY
- BD PrepMate™ Consumables Kit — BECTON DICKINSON AND COMPANY
- BD PrepStain Slide Processor — BECTON DICKINSON AND COMPANY
- BD PrepStain™ Consumables Kit — BECTON DICKINSON AND COMPANY
- BD SurePath™ Collection Vial — BECTON DICKINSON AND COMPANY
- BD SurePath™ GYN Preservative Vial Kit with Brush/Spatula — BECTON DICKINSON AND COMPANY
- BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush — BECTON DICKINSON AND COMPANY
- BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush Combi — BECTON DICKINSON AND COMPANY
- BD SurePath™ Manual Method Kit — BECTON DICKINSON AND COMPANY
- BD Syringing Pipettes — BECTON DICKINSON AND COMPANY
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (3)
- FDA UDI c2e758ec-2cec-4212-ad8a-614e9d0a0bf4 39 fields · synced Jul 9, 2026
- FDA UDI da72b3ce-55a0-4601-a1b9-20b3931c614f 36 fields · synced May 30, 2026
- EUDAMED d92cbb03-eb12-47d6-a846-c6ec154f4f68 61 fields · synced Jul 9, 2026