FDA-Device2022-09-21Class III
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Microbiologics Inc
Hazard
Product not registered for use in the UK
Sold states
International distribution to the country of United Kingdom.
Affected count
2
Manufactured in
200 Cooper Ave N, Saint Cloud, MN, United States
Products
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1740-2022Don't want to check this manually?
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