FDA-Device2021-11-17Class II
T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
BioCheck, Inc.
Hazard
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
Sold states
US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria
Affected count
314 kits
Manufactured in
425 Eccles Ave, N/A, South San Francisco, CA, United States
Products
T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0214-2022Don't want to check this manually?
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