FDA-Device2024-02-07Class II
Terragene Bionova PCD (PCD222-C)
TERRAGENE S.A.
Hazard
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Sold states
U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.
Affected count
80 stripes
Manufactured in
Ruta Nacional N 9, Km 280, Cp 2130, Parque Industrial Micropi, Alvear, Argentina
Products
Terragene Bionova PCD (PCD222-C)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0837-2024Don't want to check this manually?
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