FDA-Device2013-11-13Class III
ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
Siemens Healthcare Diagnostics, Inc
Hazard
PTH Calibrator packaged with only high calibrator.
Sold states
Nationwide Distribution including MD, PA, and CT.
Affected count
595 kits total (5 kits with packaging error)
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0173-2014Don't want to check this manually?
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