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    Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis

    FDA Recall
    Terminated ·Immuno-Mycologics, Inc·Product code GMJ·May 9, 2016

    Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis

    FDA Recall
    Open, Classified ·Immuno-Mycologics, Inc·Product code PPM·March 26, 2026

    Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE

    FDA Recall
    Open, Classified ·Immuno-Mycologics, Inc·Product code GMI·February 10, 2025

    CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919

    FDA Recall
    Terminated ·Immuno-Mycologics, Inc·Product code GMD·January 3, 2022

    Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen

    FDA Recall
    Terminated ·Immuno-Mycologics, Inc·Product code GMJ·November 4, 2019

    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.

    FDA Recall
    Terminated ·Immuno-Mycologics, Inc·Product code GMD·March 30, 2018

    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003

    FDA Recall
    Terminated ·Immuno-Mycologics, Inc·Product code GMD·December 27, 2016