Alpha-Tec Systems
Ziehl-Neelsen Carbolfuchsin Stain 250ml bottle
1manufacturer
5catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
Record
| Listed by | Alpha-Tec Systems, Inc., United States |
|---|---|
| FDA product code | ICL |
| Device type | Carbol Fuchsin |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1850 |
| Premarket notification | Exempt |
| Record published | 2022-08-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 0 | In distribution | ||
| 0 | 8 | In distribution | |
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | 8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 2 |
| Rowley Biochemical Carbol Fuchsin | Transene Company, Inc. | 1 |
| Rowley Biochemical Ziehl-Neelsen Carbol Fuchsin Solution | Transene Company, Inc. | 1 |
| AFB III Staining Kit | Ventana Medical Systems, Inc. | 1 |
| BD BBL™ TB Carbolfuchsin ZN | Becton, Dickinson AND Company | 1 |
| BenchMark Special Stains AFB Staining Kit | Ventana Medical Systems, Inc. | 1 |
| Epredia | Richard-Allan Scientific LLC | 1 |
| Rowley Biochemical Kinyoun’s Carbol Fuchsin Solution | Transene Company, Inc. | 1 |
| BD BBL™ TB Carbolfuchsin KF | Becton, Dickinson AND Company | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K890148 | 1989-01-24 |
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.