Beckman Coulter Access Hybritech p2PSA

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

から入手可能:

BECKMAN COULTER SINGAPORE PTE. LTD.

クラス:

Class C IVD

製:

Beckman Coulter Inc

治療領域:

Immunology

適応症:

It is a paramagnetic particle, chemiluminescent assay used in combination with the Access Hybritech PSA and free PSA assay to calculate the Beckman Coulter phi, a multivariate index, intended to aid the determination of the risk of prostate cancer using human serum on the Access Immunoassay Systems. Beckman Coulter phi is used as an aid in distinguishing prostate cancer from benign prostatic conditions in men agaed 50 years and older with total PSA between 2.0 to 10.0 ng/mL, with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.

製品概要:

Models: Beckman Coulter Access Hybritech p2PSA Reagent Pack - A49752, Beckman Coulter Access Hybritech p2PSA Calibrators - A49753, Beckman Coulter Access Hybritech p2PSA QC - A56934, Access® Substrate - 81906, Access® Wash Buffer II - A16792, Access® Wash Buffer II - A16793, 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, Access 2 Immunoassay Analyzer - 81600N, Unicel DxI System Software v5.1 - B47068

承認日:

2012-06-26