FDA-Device2016-01-13Class II
Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
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
590
Manufactured in
2 Edgewater Dr, N/A, Norwood, MA, United States
Products
Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0615-2016Don't want to check this manually?
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