FDA-Device2016-06-15Class II
Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
Integrated Science Systems Inc
Hazard
Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.
Sold states
Nationwide distribution to CA only.
Affected count
2625 kits
Manufactured in
1215 George C Wilson Dr Unit A4, N/A, Augusta, GA, United States
Products
Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1911-2016Don't want to check this manually?
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