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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

DateFirmReason
2012-08-10Immunodiagnostics Systems LtdIt 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
2012-08-10Immunodiagnostics Systems LtdIt 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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Data 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.