Biogenex Laboratories

3 dispositifs dans la base de données

  • Modèle / numéro de série
    Lot Numbers: AM134P1005
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide. Italy, and United Kingdom. The product was released for distribution to 21 consignees nationwide to CA, FL, GA, IA, IL, NC, NJ, NY, TX, VT, WA, and WI. One VA account: VA Medical Center, Gwen Levy, Bld. 500, Room 1238, 11301 Wilshire Blvd., Los Angeles, CA 90073. 2 overseas consignees distributed the product to Italy (Space Imports Export SPL, Via Ranzato, 12, 1-20128 Milano, Italy and United Kingdom (Launch Diagnosis, West Yoke Farm unit 11, Michaels, Lane, Sevenoaks, Kent, TN15 7EP United Kingdom
  • Description du dispositif
    Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Automated; || Model number: AM134-10MP; || Lot Numbers: AM134P1005
  • Modèle / numéro de série
    Lot Numbers: RD1340205, RD1340205X, RD1341105, RD1340206
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide. Italy, and United Kingdom. The product was released for distribution to 21 consignees nationwide to CA, FL, GA, IA, IL, NC, NJ, NY, TX, VT, WA, and WI. One VA account: VA Medical Center, Gwen Levy, Bld. 500, Room 1238, 11301 Wilshire Blvd., Los Angeles, CA 90073. 2 overseas consignees distributed the product to Italy (Space Imports Export SPL, Via Ranzato, 12, 1-20128 Milano, Italy and United Kingdom (Launch Diagnosis, West Yoke Farm unit 11, Michaels, Lane, Sevenoaks, Kent, TN15 7EP United Kingdom
  • Description du dispositif
    Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Automated; || Model Numbers: RD134-YAX; || Lot Numbers: RD1340205, RD1340205X, RD1341105, RD1340206
  • Modèle / numéro de série
    Lot Numbers: RD1340205, RD1340205X, RD1340205Y
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide. Italy, and United Kingdom. The product was released for distribution to 21 consignees nationwide to CA, FL, GA, IA, IL, NC, NJ, NY, TX, VT, WA, and WI. One VA account: VA Medical Center, Gwen Levy, Bld. 500, Room 1238, 11301 Wilshire Blvd., Los Angeles, CA 90073. 2 overseas consignees distributed the product to Italy (Space Imports Export SPL, Via Ranzato, 12, 1-20128 Milano, Italy and United Kingdom (Launch Diagnosis, West Yoke Farm unit 11, Michaels, Lane, Sevenoaks, Kent, TN15 7EP United Kingdom
  • Description du dispositif
    Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Manual; || Model Numbers: RD134-60K; || Lot Numbers: RD1340205, RD1340205X, RD1340205Y

2 fabricants avec un nom similaire

En savoir plus sur les données ici

  • Adresse du fabricant
    Biogenex Laboratories, 4600 Norris Canyon Road, San Ramon CA 94583-1320
  • Source
    USFDA
  • Adresse du fabricant
    Biogenex Laboratories, Inc., 49026 Milmont Dr, Fremont CA 94538-7301
  • Source
    USFDA