FDA-Device2013-08-07Class II
BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,
Hazard
In vitro diagnostic test kit may exhibit invalid internal negative control results.
Sold states
Nationwide Distribution
Affected count
177 kits
Manufactured in
BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, United States
Products
BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1812-2013Don't want to check this manually?
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