FDA-Device2025-04-02Class II
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Microbiologics Inc
Hazard
The RSV target may give a late Ct value and could potentially not pass QC.
Sold states
Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.
Affected count
28 units
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1454-2025Don't want to check this manually?
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