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    Associates of Cape Cod, Inc

    Manufacturer
    🇺🇸 United States·1 Importer

    ASSOCIATES OF CAPE COD, INC.

    FDA registration
    ASSOCIATES OF CAPE COD, INC.·3 products·🇺🇸 United States

    BG Analytics Software

    FDA UDI
    ASSOCIATES OF CAPE COD, INC.·00862696000289·a calculator/data processing module for clinica...

    Fungitell STAT

    FDA UDI
    ASSOCIATES OF CAPE COD, INC.·00862696000227·

    Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007

    FDA Recall
    Terminated ·Associates of Cape Cod, Inc.·Product code NQZ·August 17, 2022

    Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease 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 teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.

    FDA Enforcement
    Class II ·Terminated·Associates of Cape Cod, Inc.·May 22, 2019

    Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007

    FDA Enforcement
    Class II ·Terminated·Associates of Cape Cod, Inc.·September 28, 2022

    Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease 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 teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.

    FDA Recall
    Terminated ·Associates of Cape Cod, Inc. 124 Bernard E Saint Jean East·Product code NQZ·December 19, 2018

    TK Biotech Sp. z o.o.

    Importer
    🇵🇱 Poland·10 Manufacturers

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices