FDA-Device2012-09-26Class II
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
BD Biosciences, Systems & Reagents
Hazard
Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.
Sold states
Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.
Affected count
96 kits
Manufactured in
2350 Qume Dr, San Jose, CA, United States
Products
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2397-2012Don't want to check this manually?
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