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NQZClass II

Antigen, Invasive Fungal Pathogens

21 CFR 866.3050 / Microbiology
FDA source (opens on fda.gov)

NQZ is the FDA product code for Antigen, Invasive Fungal Pathogens, a class II device type, regulated under 21 CFR 866.3050. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NQZ
Device name
Antigen, Invasive Fungal Pathogens
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.
Regulation
21 CFR 866.3050
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
2

Clearances, product code NQZ

By decision year
2 clearances under product code NQZ with a decision year between 2004 and 2019, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NQZ by decision year
YearClearances
20041
20191

Applicants with the most clearances

Product code NQZ
Applicants holding the most 510(k) clearances under product code NQZ
ApplicantClearances
Associates of Cape Cod, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code