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NTx Urine
ZEUS SCIENTIFIC, INC. · Model NTx9006 · UDI-DI 00845533002936
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 urine.
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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