ThinPrep
CytoLyt® Solution for use as a cell wash and transport buffer in centrifuge tubes.
2manufacturers in China registered for this device type
12catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Hubei (1), Shaanxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
Record
| Listed by | Hologic, Inc., United States |
|---|---|
| FDA product code | LEA |
| Device type | Preservative, Cytological |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-09-25 |
| Record revised | 2024-04-09 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Box of 4, tray of 25, box of 2, tray of 20, box of 50, box of 20 |
| Distribution end date | 2024-05-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ThinPrep® PreservCyt® UroCyte® 30ml Kit | In distribution | |
| ThinPrep® PreservCyt® UroCyte® 20ml | In distribution | |
| ThinPrep® PreservCyt® Sol’n 946ml | In distribution | |
| ThinPrep® CytoLyt® Sol’n 30-mL tube | In distribution | |
| ThinPrep® CytoLyt® Sol’n 946ml | In distribution | |
| ThinPrep® PreservCyt® Sol’n 20ml | In distribution | |
| ThinPrep® PreservCyt® Sol’n 20ml | In distribution | |
| UroCyte Vial | In distribution | |
| ThinPrep® PreservCyt® UroCyte® 20ml | In distribution | |
| ThinPrep® CytoLyt® Sol’n 30-mL cup | In distribution | |
| ThinPrep® CytoLyt® Sol’n 30-mL cup, Int’l | Withdrawn | |
| ThinPrep® CytoLyt® Sol’n 30-mL tube, Int’l | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 28 |
| PathTezt® | Biocytech Corporation SDN BHD | 17 |
| Streck Cell Preservative | Streck LLC | 4 |
| Leica Biosystems | Leica Biosystems Richmond, Inc. | 2 |
| BD CytoRich™ Clear Preservative | Becton, Dickinson AND Company | 1 |
| MES: Freeze Medium | Lonza Walkersville, Inc. | 1 |
| Pre-prcs Prtm Frz Sol 131P0103, 50L drum | Lonza Walkersville, Inc. | 1 |
| Supmedic | Supmedics Inc. | 1 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Hologic, Inc. | UDI-DI | 2025-12-12 | Class II | Under Investigation by firm | Fungal contamination of affected lot with Parengyodontium album. | 3,728 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.