Capillarys CDT
Carbohydrate DEF Transferring BY CE
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Sebia, France |
|---|---|
| FDA product code | NAO |
| Device type | Test, Carbohydrate Deficient Transferrin |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1360 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2023-09-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C; Special storage condition: FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2009 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 7 |
| Minicap CDT Maxi KIT | Sebia | 1 |
| N Latex CDT Kit | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Capi 3 CDT | Sebia | 1 |
| Tetravalent CDT IS | Sebia | 1 |
| Capillarys CDT Maxi KIT | Sebia | 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.