FDA-Device2014-08-13Class II
AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
Advandx Inc
Hazard
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
Sold states
Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.
Affected count
10 kits
Manufactured in
400 Tradecenter, Ste 6990, Woburn, MA, United States
Products
AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2138-2014Don't want to check this manually?
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