Identity
- Trade Name
- ThinPrep Imaging System FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- Computer to operate the ThinPrep® Imager DUO System. FDA UDI
- Model / Reference
- ThinPrep Imaging System Workstation FDA UDI
- Description
- Computer to operate the ThinPrep® Imager DUO System. FDA UDI
Identifiers
- Catalog Number
- ASY-08346 FDA UDI
- Primary DI / UDI-DI
- 15420045504103 FDA UDI
- PMA Number
- P020002 FDA UDI
- FDA Product Code
- MNM FDA UDI
- GMDN Term
- Laboratory instrument/analyser application software 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: Laboratory instrument/analyser application software IVD
ThinPrep Imaging System by Hologic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P020002 also covers:
- ThinPrep Imaging System — Hologic, Inc.
- ThinPrep Imaging System — Hologic, Inc.
- ThinPrep Imaging System — Hologic, Inc.
- ThinPrep Imaging System — Hologic, Inc.
- ThinPrep Imaging System — Hologic, Inc.
- ThinPrep Imaging System — Hologic, Inc.
- ThinPrep Imaging System — Hologic, Inc.
- ThinPrep Imaging System — Hologic, Inc.
- ThinPrep Imaging System — Hologic, Inc.
- ThinPrep Imaging System — Hologic, Inc.
- ThinPrep Imaging System — Hologic, Inc.
- ThinPrep Imaging System — 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 8ea08ccc-dda9-4036-8eca-a82c3e2df308 37 fields · synced Jun 8, 2026