FDA-Device2017-09-20Class II
Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods
Leica Biosystems Richmond Inc.
Hazard
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Sold states
Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
Affected count
4
Manufactured in
5205 Route 12, N/A, Richmond, IL, United States
Products
Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3120-2017Don't want to check this manually?
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