FDA-Device2022-07-27Class II
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
LumiraDx
Hazard
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Sold states
Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.
Affected count
99 units
Manufactured in
221 Crescent St, N/A, Waltham, MA, United States
Products
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1451-2022Don't want to check this manually?
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