FDA-Device2021-09-08Class II
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Thera Test Laboratories, Inc.
Hazard
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Sold states
US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.
Affected count
11 kits
Manufactured in
1120 N Du Page Ave, N/A, Lombard, IL, United States
Products
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2381-2021Don't want to check this manually?
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