Clinical chemistry substrate IVDs

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

class:

Class 2

manufactured_by:

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

therapeutic_area:

CT833 - Clinical chemistry substrate IVDs

therapeutic_indication:

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.

authorization_status:

A

authorization_date:

2019-09-04