FDA-Device2016-05-25Class II
Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
Diamedix Corporation
Hazard
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Sold states
Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.
Affected count
588 kits
Manufactured in
14100 Nw 57th Ct, N/A, Miami Lakes, FL, United States
Products
Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1686-2016Don't want to check this manually?
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