FDA-Device2022-03-09Class II
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
Microbiologics Inc
Hazard
Real-time shelf life testing failed at 24 months
Sold states
Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.
Affected count
1 unit
Manufactured in
200 Cooper Ave N, Saint Cloud, MN, United States
Products
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0701-2022Don't want to check this manually?
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