FDA-Device2022-06-15Class II
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
NeuMoDx Molecular Inc
Hazard
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
Sold states
Domestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE, FI, FR, GB, GR, HK, ID, IT, LT, NL, SA, SE, and SI.
Affected count
459 kits US; 1626 kits OUS
Manufactured in
1250 Eisenhower Pl, Ann Arbor, MI, United States
Products
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1251-2022Don't want to check this manually?
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