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Test, Carbohydrate Deficient Transferrin
FDA product code NAO · Class 1 · Clinical Chemistry
13
Registered devices
0
Adverse events
2
Recalls
3
510(k) clearances
Devices with this code
N Latex CDT Kit — Siemens Healthcare Diagnostics Products GmbHBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.TETRAVALENT CDT IS — SEBIABIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.CAPI 3 CDT — SEBIACAPILLARYS CDT MAXI KIT — SEBIAMINICAP CDT MAXI KIT — SEBIABIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.CAPILLARYS CDT — SEBIA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-03-02 | CSL Behring GmbH | Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf l |
| 2018-05-31 | CSL Behring GmbH | Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lot |
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