FDA-Device2023-12-27Class II
ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Zeus Scientific, Inc.
Hazard
The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.
Sold states
US States: CA, MA, MI, NJ, NY, TN, UT.
Affected count
296 kits
Manufactured in
199 Evans Way, N/A, Branchburg, NJ, United States
Products
ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0602-2024Don't want to check this manually?
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