ThinPrep
For cytologic staining with the ThinPrep® system.
4manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Shandong (1), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Hangzhou Healthsky Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
Record
| Listed by | Hologic, Inc., United States |
|---|---|
| FDA product code | HZJ |
| Device type | Stain, Papanicolau |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1850 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-07-25 |
| Record revised | 2023-05-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ThinPrep® Stain Orange G Solution, 4 L | In distribution | |
| ThinPrep® Stain Nuclear Stain, 4 L | In distribution | |
| ThinPrep® Stain EA Solution, 4 L | In distribution | |
| ThinPrep® Stain Rinse II Solution, 4 L | In distribution | |
| ThinPrep® Stain Bluing II Solution, 4 L | In distribution | |
| ThinPrep® Stain Bluing Solution, 4 L | In distribution | |
| ThinPrep® Stain Rinse Solution, 4 L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 22 |
| Rowley Biochemical Hydrochloric Acid 0.25% | Transene Company, Inc. | 1 |
| Rowley Biochemical Modified Orange G | Transene Company, Inc. | 1 |
| Rowley Biochemical Scott’s Water | Transene Company, Inc. | 1 |
| Rowley Biochemical EA Counterstain | Transene Company, Inc. | 1 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 1 |
| Rowley Biochemical Orange G | Transene Company, Inc. | 1 |
| Rowley Biochemical Harris Hematoxylin | Transene Company, Inc. | 1 |
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.