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Sebia NTx Serum Test System
ZEUS SCIENTIFIC, INC. · Model XJ9021 · UDI-DI 00845533002004
10
510(k) clearances
6
Adverse events
2
Recalls
10
Facilities
Description
An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human sera.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-04-25 | Roche Diagnostics Operations, Inc. | Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the sample stability given in the Elecsys -CrossLaps (-CL) assay package ins |
| 2012-08-10 | Immunodiagnostics Systems Ltd | It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the Uni |
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