FDA-Device2018-07-18Class II
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
Dako North America Inc.
Hazard
To correct the kit's instructions for use as the storage time for gastric and gastroesophageal junction adenocarcinoma cut sections will be changed from six months to five months.
Sold states
AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, NH, NJ, NV, NY, OH, OK, PA, TX, UT, VA, WA, and WI
Affected count
1051 kits
Manufactured in
1170 Mark Ave, Carpinteria, CA, United States
Products
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2425-2018Don't want to check this manually?
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