FDA-Device2018-05-02Class III
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
Diagnostic Hybrids, Inc.
Hazard
A component of the kit was found to contain bacterial contamination.
Sold states
Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.
Affected count
107 kits
Manufactured in
2005 E State St Ste 100, N/A, Athens, OH, United States
Products
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1498-2018Don't want to check this manually?
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