Clinical chemistry substrate IVDs

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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公众评估报告 公众评估报告 (PAR)
01-11-2019

可用日期:

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

类:

Class 2

厂商:

Associates Of Cape Cod Inc 124 Bernard E Saint Jean Drive, East Falmouth, Massachusetts United States Of America

治疗领域:

CT833 - Clinical chemistry substrate IVDs

疗效迹象:

The Fungitell assay is a protease zymogen-based colorimetric assay for the qualitative detection of (1-3)-beta-D-glucan in the serum of patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)-beta-D-glucan, a major cell-wall component of various medically important fungi, can be used as an aid in the diagnosis of deep-seated mycoses and fungemias. A positive result does not indicate which genus of fungi may be causing infection.

授权状态:

A

授权日期:

2019-09-04

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