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Elecsys N-MID Osteocalcin
Roche Diagnostics GmbH · Model 07027591190 · UDI-DI 04015630940462
NEO
Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
7
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
