FDA-Device2015-09-09Class II
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Diagnostic Hybrids Inc
Hazard
Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
Sold states
Worldwide Distribution - USA, including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA; and, the countries of Canada, China, India, and Switzerland.
Affected count
171
Manufactured in
1055 E State St, Suite 100, Athens, OH, United States
Products
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0417-2015Don't want to check this manually?
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