N Latex CDT Kit
Quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum on BN II and BN ProSpec® Systems
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 | Siemens Healthcare Diagnostics Products GmbH, Germany |
|---|---|
| FDA product code | NAO |
| Device type | Test, Carbohydrate Deficient Transferrin |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1360 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K060677 |
| Record published | 2020-09-24 |
| Record revised | 2023-09-13 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10445997 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 7 |
| Capillarys CDT | Sebia | 1 |
| Minicap CDT Maxi KIT | Sebia | 1 |
| Capi 3 CDT | Sebia | 1 |
| Tetravalent CDT IS | Sebia | 1 |
| Capillarys CDT Maxi KIT | Sebia | 1 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| CSL Behring LLC | 510(k) number | 2020-03-02 | Class II | Under Investigation by firm | Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring | 297 PCK US; 1247 PCK OUS | 2020-10-05 |
| CSL Behring LLC | 510(k) number | 2018-05-31 | Class II | Under Investigation by firm | Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to the HPLC method. CDT results in absolute concentrations may | 6635 units | 2021-02-12 |
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.
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