FDA-Device2022-05-18Class I
Accula SARS-CoV-2 Test, REF: COV4100
MESA BIOTECH, INC
Hazard
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Sold states
US Nationwide distribution in the states of CA, TX, MA, NY, FL, NC, NJ, GA, CO, HI, PA, WA, NY, VA, MD, KY, WI, IL, PR, ND, MI, TN, AZ, UT.
Affected count
6162
Manufactured in
6190 Cornerstone Ct E Ste 220, N/A, San Diego, CA, United States
Products
Accula SARS-CoV-2 Test, REF: COV4100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1009-2022Don't want to check this manually?
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