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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0965-2015

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.

Publicado el 21 de enero de 2015 · Inicio del retiro: 12 de diciembre de 2014

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.

Qué hacer

Voluntary: Firm initiated · Telephone

Detalles del retiro

Fabricante
Biocare Medical Llc
Distribuidor
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.
Lote
Lot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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