Clinical chemistry substrate IVDs

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

classe:

Class 2

Fabriqué par:

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

Domaine thérapeutique:

CT833 - Clinical chemistry substrate IVDs

indications thérapeutiques:

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.

Statut de autorisation:

A

Date de l'autorisation:

2019-09-04