FDA-Device2014-02-12Class II
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
Siemens Healthcare Diagnostics, Inc
Hazard
ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia,Brazil,Canada, Columbia, China, Ecuador, Egypt, India, Japan, Korea, Mexico, Saudi Arabia,Singapore, Thailand, and Uruguay.
Affected count
1294 (144 units US)
Manufactured in
333 Coney St, East Walpole, MA, United States
Products
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0930-2014Don't want to check this manually?
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