3 results
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8ms
·
Sources: EU EUDAMED, US FDA
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
FDA Enforcement
Class I
·Ongoing·Jiangsu Well Biotech Co.,Ltd.·October 19, 2022
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
FDA Enforcement
Class I
·Ongoing·Lusys Laboratories, Inc.·March 16, 2022
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
FDA Enforcement
Class I
·Ongoing·Lusys Laboratories, Inc.·March 16, 2022