Identity
- Trade Name
- ThinPrep Imaging System FDA UDI
- Generic Name
- Basic light microscope FDA UDI
- Device Name
- An automated microscope used to screen ThinPrep® pap test slides that have been imaged by a ThinPrep® Image Processor. FDA UDI
- Model / Reference
- ThinPrep Imaging System Review Scope FDA UDI
- Description
- An automated microscope used to screen ThinPrep® pap test slides that have been imaged by a ThinPrep® Image Processor. FDA UDI
Identifiers
- Catalog Number
- ASY-07234 FDA UDI
- Primary DI / UDI-DI
- 15420045500907 FDA UDI
- PMA Number
- P020002 FDA UDI
- FDA Product Code
- MNM FDA UDI
- GMDN Term
- Basic light microscope 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: Basic light microscope
ThinPrep Imaging System by Hologic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic light microscope.
- LW Scientific, Inc. — LW SCIENTIFIC, INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- LW Scientific, Inc. — LW SCIENTIFIC, INC. · Class I
- SPECWELL — SPECWELL CORPORATION · Class I
- SPECWELL — SPECWELL CORPORATION · Class I
- SPECWELL — SPECWELL CORPORATION · Class I
- SEILER MEDICAL DIVISION — SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED · Class I
- LW Scientific, Inc. — LW SCIENTIFIC, INC. · Class I
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 967b2c1b-0dc6-40ba-bafc-e3f42ad724b1 37 fields · synced Jun 8, 2026