Identity
- Trade Name
- BD PrepStain™ Install Kit FDA UDI
- Generic Name
- Endocervical specimen cytological examination kit IVD FDA UDI
- Device Name
- BD PrepStain™ Install Kit FDA UDI
- Model / Reference
- 491289 FDA UDI
- Description
- BD PrepStain™ Install Kit FDA UDI
Identifiers
- Catalog Number
- 491289 FDA UDI
- Primary DI / UDI-DI
- 00382904912895 FDA UDI
- PMA Number
- P970018 FDA UDI
- FDA Product Code
- MKQ FDA UDI
- GMDN Term
- Endocervical specimen cytological examination kit IVD FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
BD PrepStain™ Install Kit by Becton Dickinson And Company — Class III — FDA UDI — listed in FDA GUDID — 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 (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 851f9e93-e950-4fb0-af2b-517b46ff7ff5 38 fields · synced May 30, 2026