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System, Test, Osteocalcin

FDA product code NEO · Class 2 · Clinical Chemistry

3
Registered devices
1
Adverse events
2
Recalls
2
510(k) clearances

Devices with this code

Elecsys NMID Osteocalcin Immunoassay — Roche Diagnostics GmbHElecsys N-MID Osteocalcin — Roche Diagnostics GmbHN-MID® Osteocalcin ELISA — IMMUNODIAGNOSTIC SYSTEMS LIMITED

Recent 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 sal
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 sal

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.