FDA-Device2023-04-05Class II
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
Quidel Corporation
Hazard
Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
Sold states
not yet available
Affected count
771 units
Manufactured in
2005 E State St Ste 100, N/A, Athens, OH, United States
Products
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1308-2023Don't want to check this manually?
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