Beckman Coulter VERIS HBV Assay Reagent System

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:

Microbiology

適応症:

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.

製品概要:

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

承認日:

2016-12-12