FDA-Device2021-09-08Class II
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Thera Test Laboratories, Inc.
Hazard
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
Sold states
US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.
Affected count
19 kits
Manufactured in
1120 N Du Page Ave, N/A, Lombard, IL, United States
Products
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2382-2021Don't want to check this manually?
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