Beckman Coulter VERIS HBV Assay Reagent System

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:
Microbiology
Therapeutic indications:
The VERIS HBV Assay is intended for use on human K2EDTA plasma and serum as an aid in the management of HBV-infected individuals undergoing antiviral therapy in conjunction with clinical presentation and other laboratory markers. The assay measures HBV DNA levels at baseline and during treatment and can be used to aid in assessing response to treatment. The results from the VERIS assay must be interpreted within the context of all relevant clinical and laboratory findings. This test is not intended for use as a screening test for the presence of HBV in blood or blood products or as a diagnostic test to confirm the presence of HBV infection.
Product summary:
Models: VERIS HBV Assay Reagent Pack - B15522, VERIS HBV Calibration Adjusters - B15523, VERIS EP Cartridge A - B15532, VERIS EP Cartridge B - B15533, VERIS HBV Assay Starter Kit - B37878, DxN VERIS System. - B23158, B15532, B15533, DxN VERIS System. software version 1.4 - B85540
Authorization number:
DE0018788
Authorization date:
2016-12-12

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