FDA-Device2016-01-13Class II
Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer Catalog Number: CCCRP SMN:10445066
Siemens Healthcare Diagnostics Inc
Hazard
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Sold states
Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
Affected count
78
Manufactured in
2 Edgewater Dr, N/A, Norwood, MA, United States
Products
Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer Catalog Number: CCCRP SMN:10445066
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0614-2016Don't want to check this manually?
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