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Sign in to claim this brandImmuno-Mycologics, Inc.
US
Last updated May 26, 2026
Information
- Country
- US
- Address
- —
- Website
- immy.com
- —
- —
- [email protected]
- Phone
- 14053604669
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 099550915
Catalogue (104)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Immy | AD0110 | FDA UDI | Class I | Active |
| Immy | A20110 | FDA UDI | Class I | Active |
| Immy | HGMNC1 | FDA UDI | Class I | Active |
| Immy | AE0110 | FDA UDI | Class I | Active |
| Immy | ID1029 | FDA UDI | Class I | Active |
| Immy | CR1004 | FDA UDI | Class II | Active |
| Immy | ID1039 | FDA UDI | Class I | Active |
| Immy | TBPN67 | FDA UDI | Class I | Active |
| Immy | C40110 | FDA UDI | Class II | Active |
| Immy | A10150 | FDA UDI | Class I | Active |
| Immy | H10150-M | FDA UDI | Class II | Active |
| Immy | H20110 | FDA UDI | Class II | Active |
| Immy | B20110 | FDA UDI | Class II | Active |
| Immy | TBPN67-500 | FDA UDI | Class I | Active |
| Immy | C60110 | FDA UDI | Class II | Active |
| Immy | CAB102 | FDA UDI | Class II | Active |
| Immy | B10150 | FDA UDI | Class II | Active |
| Immy | YA1001 | FDA UDI | Class II | Active |
| Immy | H30150 | FDA UDI | Class II | Active |
| Immy | CRY101 | FDA UDI | Class II | Active |
| Immy | C10150 | FDA UDI | Class II | Active |
| Immy | HGM000 | FDA UDI | Class I | Active |
| Immy | CR1003 | FDA UDI | Class II | Active |
| Immy | A70110 | FDA UDI | Class I | Active |
| Immy | C10150-M | FDA UDI | Class II | Active |
| Immy | AG0110 | FDA UDI | Class I | Active |
| Immy | A80110 | FDA UDI | Class I | Active |
| Immy | B40110 | FDA UDI | Class II | Active |
| Immy | EIABU3 | FDA UDI | Class I | Active |
| Immy | EI0010 | FDA UDI | Class II | Active |
| Immy | TBRB30 | FDA UDI | Class I | Active |
| Immy | QDXH90 | FDA UDI | Class II | Active |
| Immy | QDXC90 | FDA UDI | Class II | Active |
| Immy | DDR012-3.0 | FDA UDI | Class I | Active |
| Immy | C30110 | FDA UDI | Class II | Active |
| Immy | H30150-M | FDA UDI | Class II | Active |
| Immy | A30110 | FDA UDI | Class I | Active |
| Immy | C20110 | FDA UDI | Class II | Active |
| Immy | B10150-M | FDA UDI | Class II | Active |
| Immy | CR2003 | FDA UDI | Class II | Active |
| Immy | MPB075-3.0 | FDA UDI | Class I | Active |
| Immy | CB0050 | FDA UDI | Class I | Active |
| Immy | TBP300 | FDA UDI | Class I | Active |
| Immy | SL1001 | FDA UDI | Class I | Active |
| Immy | AA0110 | FDA UDI | Class I | Active |
| Immy | QDXB50 | FDA UDI | Class II | Active |
| Immy | DDR012-2.5 | FDA UDI | Class I | Active |
| Immy | C50110 | FDA UDI | Class II | Active |
| Immy | HAG102 | FDA UDI | Class II | Active |
| Immy | ID1019 | FDA UDI | Class I | Active |
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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.
| 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. |