Siemens ADVIA Centaur BR Assay

  • Modelo / Serial
    BR Assay for CA 27.29 BR Assay Kit Lots ReadyPack¿ Lot Number Ending in 198:. 89291198,86469198,85752198,88939198, 87757198, 85459198, 88319198, 86295198, 85194198  ReadyPack¿ Lot Number Ending in 202:  93573202, 91045202, 93664202, 90880202, 93157202,91126202,90494202.  BR Assay for CA 15-3 ReadyPack BR Assay Kit Lots Lot Number Ending in 199:  87425199,85862199,86949199,85945199
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain.
  • Descripción del producto
    Siemens ADVIA Centaur BR Assay: Catalog Number: || US: REF 02419937 (10214722) (50 Tests); || REF 03896216(10334837)(250 Tests) Not || CE Marked; OUS: || REF03204829(10310271)(50 Tests); REF || 01157807(1 0314722) (250 Tests) CE || Marked; REF 09010686 (10340081)(250 Tests). || The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

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