D3
Mounting Fluid (pH 8.0-8.4)
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Dakewe BIO-Engineering Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Diagnostic Hybrids, Inc., United States |
|---|---|
| FDA product code | LEB |
| Device type | Mounting Media |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Premarket notification | Exempt |
| Record published | 2019-04-23 |
| Record revised | 2024-07-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-002007b | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 23 |
| Mounting medium (Iift) | Euroimmun Medizinische Labordiagnostika AG | 3 |
| Fluoro Care Anti-Fade Mountant | Biocare Medical, LLC | 2 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 2 |
| EcoMount | Biocare Medical, LLC | 1 |
| Mounting Medium | Euroimmun Medizinische Labordiagnostika AG | 1 |
| ClaraMount™ Coverslip mounting medium | Clarapath, Inc. | 1 |
| Trinity Biotech | Mardx Diagnostics, 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.