FDA-Device2025-03-26Class II
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Microbiologics Inc
Hazard
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Sold states
US Nationwide distribution in the states of TX. UK.
Affected count
6 units
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1371-2025Don't want to check this manually?
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