Identity
- Trade Name
- ThinPrep® Pap Test FDA UDI
- Generic Name
- Cytology specimen container IVD, transport buffer FDA UDI
- Device Name
- For use with the ThinPrep® system to preserve gynecological specimens. FDA UDI
- Model / Reference
- ThinPrep® CervTM PreservCyt® Sol'n 20ml FDA UDI
- Description
- For use with the ThinPrep® system to preserve gynecological specimens. FDA UDI
Identifiers
- Catalog Number
- PRD-07003-001 FDA UDI
- Primary DI / UDI-DI
- 15420045514652 FDA UDI
- PMA Number
- P950039 FDA UDI
- FDA Product Code
- MKQ FDA UDI
- GMDN Term
- Cytology specimen container IVD, transport buffer FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- 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
No
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
Category: Cytology specimen container IVD, transport buffer
ThinPrep® Pap Test by Hologic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cytology specimen container IVD, transport buffer.
- Babio — Jinan Babio Biotechnology Co., Ltd. · Class I
- Babio — Jinan Babio Biotechnology Co., Ltd. · Class I
- BD CytoRich™ Clear Collection Vial — BECTON DICKINSON AND COMPANY · Class I
- BD SurePath™ Collection Vial — BECTON DICKINSON AND COMPANY · Class III
- ThinPrep® Pap Test — Hologic, Inc. · Class III
Cleared under the same submission
P950039 also covers:
- ThinPrep — Hologic, Inc.
- ThinPrep — Hologic, Inc.
- ThinPrep — Hologic, Inc.
- ThinPrep — Hologic, Inc.
- ThinPrep 2000 Processor — Hologic, Inc.
- ThinPrep 2000 Processor — Hologic, Inc.
- ThinPrep 5000 Processor — Hologic, Inc.
- ThinPrep 5000 Processor — Hologic, Inc.
- ThinPrep 5000 Processor — Hologic, Inc.
- ThinPrep Imaging System — Hologic, Inc.
- ThinPrep Imaging System — Hologic, Inc.
- ThinPrep Pap Test — Hologic, Inc.
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
- Hologic, Inc.
Sources (1)
- FDA UDI 30012bb8-784e-4b6a-b01d-57e09b3fa22a 37 fields · synced May 31, 2026