NQZ

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Antigen, Invasive Fungal Pathogens

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3050

Medical specialty

Microbiology

FDA definition

Invasive fungal pathogen assays are devices that consist of antigens, antisera, or proteases used in serological assays for the presumptive diagnosis of fungal infection in serum or plasma. The assay is indicated for use in patients with symptoms of, or medical conditions predisposing the patient to invasive fungal infection. The device can be used as an aid in the diagnosis of deep seated mycoses and fungemias. A positive result does not indicate which class of fungi may be causing infection. The assays should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.

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