FDA-Device2022-03-16Class I
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Lusys Laboratories, Inc.
Hazard
COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Sold states
Worldwide - US Nationwide distribution in the states of CA, NC, NV, OH, TN and TX. The countries of Canada, China, and Mexico. Pending additional information for a complete Consignee Listing
Affected count
90,849 kits
Manufactured in
7220 Trade St Ste 338, N/A, San Diego, CA, United States
Products
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0717-2022Don't want to check this manually?
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