Device Recall MUM1BC5, Concentrated and Prediluted Rabbit Monoclonal antibody

  • Model / Serial
    Lot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distrinution - US Nationwide in the states of TX, WI, MO, WV, SC, MA, WA, TN, AZ, CA, IL, NY, LA and countries of Kuwait, India, Venezuela, New Zealand, Turkey, Uruguay.
  • Product Description
    MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; || Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies || : || Multiple myeloma oncogene-1 (MUM-1) is a protein encoded by MUM-1 gene. MUM-1 protein is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B-cells located in the light zone. MUM-1 [BC5] labels MUM-1protein in centrocytes and their progeny, plasma cells, activated T-cells and a wide spectrum of hematolymphoid neoplasms derived from these cells. MUM-1 has been reported to play an important role in mediating B-cell activation and differentiation.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biocare Medical Llc, 4040 Pike Ln, Concord CA 94520-1227
  • Manufacturer Parent Company (2017)
  • Source
    USFDA