Device Recall MSH6 (44 Mab) CM

  • Modèle / numéro de série
    Product Code PA0804, Lot No. 45973, Exp. Date 05/21/2019
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, || The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Leica Biosystems Richmond Inc., 5205 Route 12, Richmond IL 60071
  • Société-mère du fabricant (2017)
  • Source
    USFDA