Rowley Biochemical Scott’s Water
Scott's Water Solution for Papanicolau Staining
4manufacturers in China registered for this device type
1catalogue number
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 | Transene Company, Inc., United States |
|---|---|
| FDA product code | HZJ |
| Device type | Stain, Papanicolau |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1850 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-09-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Total volume 4 to 8 Fluid Ounce; total volume 1 Gallon; total volume 1 Quart; total volume 1 Pint |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Total Volume 1 Gallon | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 22 |
| ThinPrep | Hologic, Inc. | 7 |
| Rowley Biochemical Hydrochloric Acid 0.25% | Transene Company, Inc. | 1 |
| Rowley Biochemical Modified Orange G | 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.