Identity
- Trade Name
- ThinPrep® FDA UDI
- Generic Name
- General tissue specimen container IVD, fixative/saline FDA UDI
- Device Name
- CytoLyt® Solution for use as a cell wash and transport buffer in centrifuge tubes. FDA UDI
- Model / Reference
- ThinPrep® CytoLyt® Sol'n 30-mL tube FDA UDI
- Description
- CytoLyt® Solution for use as a cell wash and transport buffer in centrifuge tubes. FDA UDI
Identifiers
- Catalog Number
- PRD-07064 FDA UDI
- Primary DI / UDI-DI
- 15420045514607 FDA UDI
- FDA Product Code
- LEA FDA UDI
- GMDN Term
- General tissue specimen container IVD, fixative/saline FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General tissue specimen container IVD, fixative/saline
ThinPrep® by Hologic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI 3ed1f758-3c2e-4de9-96d7-25fa4f2c4f4f 36 fields · synced Jun 8, 2026