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Immuno-Mycologics, Inc.

US

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 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
Immy CD0110
FDA UDI
Class IIActive
Immy AF0110
FDA UDI
Class IActive
Immy CA1019
FDA UDI
Class IActive
Immy NAOH25
FDA UDI
Class IActive
Immy DE0010
FDA UDI
Class IActive
Immy ID1001
FDA UDI
Class IIActive
Immy A90110
FDA UDI
Class IActive
Immy CL1001
FDA UDI
Class IIActive
Immy HL1001
FDA UDI
Class IIActive
Immy CA1001
FDA UDI
Class IIActive
Immy HGMPC1
FDA UDI
Class IActive
Immy N80110
FDA UDI
Class IIActive
Immy H50110
FDA UDI
Class IIActive
Immy H60110
FDA UDI
Class IIActive
Immy BTA101
FDA UDI
Class IIActive
Immy CI1001
FDA UDI
Class IIActive
Immy B30110
FDA UDI
Class IIActive
Immy GLF065
FDA UDI
Class IIActive
Immy CTA2003
FDA UDI
Class IIActive
Immy MPB075-2.5
FDA UDI
Class IActive
Immy C70110
FDA UDI
Class IIActive
Immy QDXH70
FDA UDI
Class IIActive
Immy NAOH30
FDA UDI
Class IActive
Immy A40110
FDA UDI
Class IActive
Immy H10150
FDA UDI
Class IIActive
Immy HAG000
FDA UDI
Class IActive
Immy H40110
FDA UDI
Class IIActive
Immy HGMDAB
FDA UDI
Class IActive
Anti-Histoplasma Serum #cf10026x K791392
FDA 510(k)
Class IIActive
Exo-Antigen Identification System Cat.# Ex1001 K880029
FDA 510(k)
Class IIActive
Alpha Cryptococcal Antigen Eia K120946
FDA 510(k)
Class IIActive
Capik-Candida Albicans Ident. Kit. K800908
FDA 510(k)
Class IActive
Crag Lateral Flow Assay (crag Lfa) K102286
FDA 510(k)
Class IIActive
Aspergillus Mycelial Antigen #cf10024x K791387
FDA 510(k)
Class IActive
Cryptococcal Antigen Latex Agglutination K791382
FDA 510(k)
Class IIActive
La-Staph Identification System K831918
FDA 510(k)
Class IActive
Candida Immunodiffusion Kit #ca1001 K791383
FDA 510(k)
Class IIActive
Histoplasma Yeast Anti #cf10021x K791393
FDA 510(k)
Class IIActive
Fungal Immunodiffusion Kit #id1001 K791384
FDA 510(k)
Class IIActive
Coccidioides Antigen #cf10023x K791389
FDA 510(k)
Class IIActive
Ya-Crypto Antibody Tube Agglutination K810510
FDA 510(k)
Class IIActive
Ei-Candida Enzyme Immunoassay Ei1001 K843286
FDA 510(k)
Class IIActive
Negative Control Serum For Cf Ro Id K791385
FDA 510(k)
Class IIActive
La-Histo Antibody System #hl 1001 K830837
FDA 510(k)
Class IIActive
Rabbit Plasma Fibrinogen (rpf) Supplement K883333
FDA 510(k)
Class IActive
Anti-Histoplasma Serum #cf10025x K791395
FDA 510(k)
Class IIActive
Anti-Blastomyces Serum #cf10027x K791390
FDA 510(k)
Class IIActive
Histoplasma Mycelial #cf10020x K791394
FDA 510(k)
Class IIActive
La-Sporo Antibody System K802427
FDA 510(k)
Class IActive
Crag Lateral Flow Assay (lfa) K112422
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

DateRecall No.ClassStatusReason
Mar 26, 2026Z-1984-2026—open, classified

Neutralization Buffer may contain contaminants

Feb 10, 2025Z-1389-2025—open, classified

Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.

Jan 3, 2022Z-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, 2019Z-2301-2020—terminated

False positive results due to potential contamination of reagent.

Mar 30, 2018Z-2409-2018—terminated

Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results

Dec 27, 2016Z-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, 2016Z-2040-2016—terminated

The device was found to have bacterial contamination.