FDA-Device2018-09-26Class I
VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
Hazard
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers
Sold states
worldwide
Affected count
559 units
Manufactured in
1910 E Innovation Park Dr, N/A, Oro Valley, AZ, United States
Products
VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3008-2018Don't want to check this manually?
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