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510(k) K191167

Fungitell STAT by Associates of Cape Cod, Inc. — Product Code NQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2019
Date Received
May 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Invasive Fungal Pathogens
Device Class
Class II
Regulation Number
866.3050
Review Panel
MI
Submission Type

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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