FDA-Device2018-05-09Class II
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
Siemens Healthcare Diagnostics, Inc.
Hazard
May produce erroneously low results from specific well sets.
Sold states
Worldwide Distribution - USA (nationwide) and to the following countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Japan, Norway, Portugal, Slovakia, Slovenia, South Korea, Spain, Switzerland
Affected count
6000
Manufactured in
500 Gbc Dr Ms 514, Po Box 6101, Newark, DE, United States
Products
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1540-2018Don't want to check this manually?
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