Rowley Biochemical Orange G
Orange G Staining 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 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 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.