FDA-Device2021-09-22Class II
Verigene EP Amplification Reagent Kit Test
Luminex Corporation
Hazard
There is potential for false positive results.
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.
Affected count
4579 kits
Manufactured in
4088 Commercial Ave, N/A, Northbrook, IL, United States
Products
Verigene EP Amplification Reagent Kit Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2451-2021Don't want to check this manually?
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