Identity
- Trade Name
- ThinPrep Imaging System FDA UDI
- Generic Name
- Cervical cytology microscopy slide IVD FDA UDI
- Device Name
- Glass slides or use with ThinPrep® processors and ThinPrep® Imaging Systems for gynecological specimens. FDA UDI
- Model / Reference
- ThinPrep® Imaging System Microscope Slides, 100pk FDA UDI
- Description
- Glass slides or use with ThinPrep® processors and ThinPrep® Imaging Systems for gynecological specimens. FDA UDI
Identifiers
- Catalog Number
- ASY-07317 FDA UDI
- Primary DI / UDI-DI
- 25420045501093 FDA UDI
- PMA Number
- P950039 FDA UDI
- FDA Product Code
- MKQ FDA UDI
- GMDN Term
- Cervical cytology microscopy slide 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cervical cytology microscopy slide IVD
ThinPrep Imaging System by Hologic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cervical cytology microscopy slide IVD.
- MDHC — MDHC Life Technologies (Kunshan) Co., LTD. · Class I
- CELLPRESERV KOLPLAST — Kolplast CI SA · Class I
- BD SurePath™ PreCoat Slides — BECTON DICKINSON AND COMPANY · Class III
- ThinPrep — Hologic, Inc. · Class I
- 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 Pap Test — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI ca8077f1-eecc-48de-bcb1-b650adecbcd9 36 fields · synced May 30, 2026