7 results
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44ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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 Enforcement
Class II
·Ongoing·Immuno-Mycologics, Inc·May 6, 2026
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 Enforcement
Class II
·Terminated·Immuno-Mycologics, Inc·July 18, 2018
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 Enforcement
Class II
·Terminated·Immuno-Mycologics, Inc·June 29, 2016
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
FDA Enforcement
Class II
·Terminated·Immuno-Mycologics, Inc·February 8, 2017
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 Enforcement
Class II
·Terminated·Immuno-Mycologics, Inc·June 17, 2020
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 Enforcement
Class II
·Terminated·Immuno-Mycologics, Inc·February 9, 2022
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 Enforcement
Class II
·Ongoing·Immuno-Mycologics, Inc·March 26, 2025