Beckman Coulter Access Hybritech PSA

Singapore - English - HSA (Health Sciences Authority)

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Available from:
BECKMAN COULTER SINGAPORE PTE. LTD.
Class:
Class C IVD
Manufactured by:
Beckman Coulter Inc
Therapeutic area:
Immunology
Therapeutic indications:
It is a paramagnetic particle, chemiluninescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsayis required for the diagnosis of cancer. The device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.
Product summary:
Models: Access Hybritech PSA Reagent Pack - 37200, Beckman Coulter Access Hybritech PSA Calibrators - 37205, Beckman Coulter Access Hybritech Sample Diluent - 37206, Beckman Coulter Access Hybritech PSA QC - 37209, Access® Substrate - 81906, Access® Wash Buffer II - A16792, Access® Wash Buffer II - A16793, Access® Wash Buffer II (Diluent Pack) - A79784, UniCel Dxi 800 ACCESS Immunoassay Analyzer - 973100, UniCel DxI 600 ACCESS Immunoassay Analyzer - A30260, UniCel DxI 800 ACCESS Immunoassay W/Spot B - A71456, UniCel DxI 800 ACCESS Immunoassay W/Dual Gantry - A71457, UniCel DxI 600 ACCESS Immunoassay W/Spot B - A71460, UniCel DxI 600 Access Immunoassay W/Dual Gantry - A71461, Unicel DxI System Software v5.1 - B47068
Authorization number:
DE0009317
Authorization date:
2012-06-26

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