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,
Becton Dickinson & Co.
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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