Identity
- Trade Name
- BD Totalys SlidePrep FDA UDI
- Generic Name
- Microscope slide maker/stainer IVD FDA UDI
- Device Name
- BD Totalys SlidePrep FDA UDI
- Model / Reference
- 491346 FDA UDI
- Description
- BD Totalys SlidePrep FDA UDI
Identifiers
- Catalog Number
- 491346 FDA UDI
- Primary DI / UDI-DI
- 00382904913465 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
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
Category: Microscope slide maker/stainer IVD
BD Totalys SlidePrep 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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- 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:
- 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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI a37bfa43-3704-4a93-868f-77debeec45ee 36 fields · synced Jun 8, 2026