FDA-Device2019-08-28Class II
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Aniara Diagnostica LLC
Hazard
Residual crystallization of the microplate and recurrent negative controls out of range.
Sold states
Distribution to US states of NC, NH, NY, and OH, and Sweden.
Affected count
51
Manufactured in
7768 Service Center Dr, N/A, West Chester, OH, United States
Products
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2346-2019Don't want to check this manually?
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