FDA-Device2021-11-10Class II
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Siemens Healthcare Diagnostics, Inc
Hazard
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
Sold states
US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.
Affected count
149 kits
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0195-2022Don't want to check this manually?
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