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Immuno-Mycologics, Inc.

Last updated May 26, 2026

What Immuno-Mycologics, Inc. makes

The company produces in vitro diagnostic reagents and controls for detecting fungal antibodies, including Histoplasma capsulatum, Coccidioides immitis, Blastomyces dermatitidis, and multiple Aspergillus species. It also supplies reagents for Candida albicans IgG/IgM antibody testing and kits for preparing agar media. Sputum liquefaction and decontamination reagents are part of its diagnostic portfolio.

These products are regulated under FDA Class I and Class II categories, with some authorised via 510(k) premarket notifications and others through the De Novo pathway. The company’s devices are listed in the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: immy.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 14053604669
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 099550915

Catalogue (104)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Alpha Histoplasma Antigen Eia Model Hag102	K101407	FDA 510(k)	Class II	Active
Coccidiodes (cocci)	K791381	FDA 510(k)	Class II	Active
Anti-Aspergillus (mycelial) Contr Serum	K791386	FDA 510(k)	Class I	Active
Anti-Coccidioides Serum #cf10028x	K791388	FDA 510(k)	Class II	Active

Related Companies

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FDA Recalls (7)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Immuno-Mycologics, Inc. has seven FDA recall records spanning from May 9, 2016, to March 26, 2026, with statuses including open, classified, and terminated. The recalls involve concerns such as potential contaminants in neutralization buffers, reduced specificity or sensitivity in immunoassay products (leading to possible false positives or negatives), bacterial contamination in devices, and issues with lateral flow assay (LFA) strips improperly wicking, which may affect test accuracy. Reasons also include reagent contamination causing false positives and variations in specificity percentages between affected and unaffected product lots.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Mar 26, 2026	Z-1984-2026	—	open, classified	Neutralization Buffer may contain contaminants
Feb 10, 2025	Z-1389-2025	—	open, classified	Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Jan 3, 2022	Z-0545-2022	—	terminated	The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number of samples with positive test results may be false positives, which may cause some patients to initiate unnecessary anti-fungal therapy. Samples with negative test results are NOT affected.
Nov 4, 2019	Z-2301-2020	—	terminated	False positive results due to potential contamination of reagent.
Mar 30, 2018	Z-2409-2018	—	terminated	Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
Dec 27, 2016	Z-1109-2017	—	terminated	The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.
May 9, 2016	Z-2040-2016	—	terminated	The device was found to have bacterial contamination.