Data / Medical devices / United States / IMMY, Inc.
IMMY, Inc.: FDA-registered device maker in Norman, OK, United States, 20 510(k) clearances
IMMY, Inc. is registered with the FDA (registration 1627497) in Norman, OK, United States. It lists 25 device types. The FDA files 20 510(k) clearances under its listings, the newest dated March 28, 2012. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1627497
- Address
- 2701 Corporate Centre Dr, Norman, OK, United States, 73069
- Owner or operator
- IMMY, Inc. (Immunomycologics, Inc.) (9916020)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- November 21, 1979
- Registered through
- 2027
- Brand names listed
- A10150 - Aspergillus CF Antigen Dilute, A20110 - Aspergillus CF Positive Control, A30110 - Aspergillus ID Antigen, A40110 - Aspergillus ID Positive Control, A70110 - A. Fumigatus ID Antigen, A80110 - A. Fumigatus ID Positive Control, A90110 - A. Flavus ID Antigen, AA0110 - A. Flavus ID Positive Control and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigen, Blastomyces Dermatitidis, Other | LSH | 2 | Manufacturer | accessdata.fda.gov |
| Antigen, Cf And / Or Id, Coccidioides Immitis | GMI | 2 | Manufacturer | accessdata.fda.gov |
| Antigen, Cf, Aspergillus Spp. | JWT | 1 | Manufacturer | accessdata.fda.gov |
| Antigen, Elisa, Cryptococcus | MDU | 2 | Manufacturer | accessdata.fda.gov |
| Antigen, Latex Agglutination, Coccidioides Immitis | GMG | 2 | Manufacturer | accessdata.fda.gov |
| Antigens, Histoplasma Capsulatum, All | GMJ | 2 | Manufacturer | accessdata.fda.gov |
| Antisera, Fluorescent, Sporothrix Schenekii | GMA | 1 | Manufacturer | accessdata.fda.gov |
| Antisera, Latex Agglutination, Cryptococcus Neoformans | GMD | 2 | Manufacturer | accessdata.fda.gov |
| Antiserum, Blastomyces Dermatitidis, Other | LSI | 2 | Manufacturer | accessdata.fda.gov |
| Antiserum, Positive And Negative Febrile Antigen Control Serum | GSN | 2 | Manufacturer | accessdata.fda.gov |
| Antiserum, Positive Control, Aspergillus Spp. | KFG | 1 | Manufacturer | accessdata.fda.gov |
| Antiserum, Positive Control, Coccidioides Immitis | GMH | 2 | Manufacturer | accessdata.fda.gov |
| Antiserum, Positive Control, Histoplasma Capsulatum | GMK | 2 | Manufacturer | accessdata.fda.gov |
| Candida Species Nucleic Acid Detection System | PII | 2 | Manufacturer for export | accessdata.fda.gov |
| Candida Species, Antibody Detection | LSG | 2 | Manufacturer | accessdata.fda.gov |
| Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens | QAA | 2 | Manufacturer for export | accessdata.fda.gov |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | 1 | Manufacturer | accessdata.fda.gov |
| Eia, Blastomyces Dermatitidis | MJL | 2 | Manufacturer | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum | MIZ | 2 | Manufacturer | accessdata.fda.gov |
| Enzyme Linked Immunosorbent Assay, Coccidioides Immitis | MIY | 2 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls Unassayed | OHQ | 1 | Manufacturer | accessdata.fda.gov |
| Plates, Ouchterlony Agar | JZP | 1 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
| Slides, Microscope | KEW | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 28, 2012 | K112422 | CRAG LATERAL FLOW ASSAY (LFA) | GMD | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| July 20, 2011 | K102286 | CRAG LATERAL FLOW ASSAY (CRAG LFA) | GMD | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| July 19, 2011 | K101407 | ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 | MIZ | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| May 5, 1983 | K830837 | LA-HISTO ANTIBODY SYSTEM #HL 1001 | GMJ | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| March 20, 1981 | K810510 | YA-CRYPTO ANTIBODY TUBE AGGLUTINATION | GMD | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| October 31, 1980 | K802427 | LA-SPORO ANTIBODY SYSTEM | GMA | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791395 | ANTI-HISTOPLASMA SERUM #CF10025X | GMK | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791394 | HISTOPLASMA MYCELIAL #CF10020X | GMJ | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791393 | HISTOPLASMA YEAST ANTI #CF10021X | GMJ | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791392 | ANTI-HISTOPLASMA SERUM #CF10026X | GMK | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791390 | ANTI-BLASTOMYCES SERUM #CF10027X | GMK | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791389 | COCCIDIOIDES ANTIGEN #CF10023X | GMI | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791388 | ANTI-COCCIDIOIDES SERUM #CF10028X | GMH | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791387 | ASPERGILLUS MYCELIAL ANTIGEN #CF10024X | JWT | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791386 | ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM | KFG | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791385 | NEGATIVE CONTROL SERUM FOR CF RO ID | GSN | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791384 | FUNGAL IMMUNODIFFUSION KIT #ID1001 | GMJ | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791383 | CANDIDA IMMUNODIFFUSION KIT #CA1001 | GMI | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791382 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION | GMD | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
| August 16, 1979 | K791381 | COCCIDIODES (COCCI) | GMG | Substantially Equivalent | Immuno-Mycologics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 26, 2026 | 98702 | Class II | Ongoing | Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis | Neutralization Buffer may contain contaminants | accessdata.fda.gov |
| February 10, 2025 | 96315 | Class II | Ongoing | 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 | Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results. | accessdata.fda.gov |
| January 3, 2022 | 89370 | Class II | Terminated | 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 | 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 result | accessdata.fda.gov |
| November 4, 2019 | 85368 | Class II | Terminated | 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 A | False positive results due to potential contamination of reagent. | accessdata.fda.gov |
| March 30, 2018 | 80284 | Class II | Terminated | 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 pol | Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results | accessdata.fda.gov |
| December 27, 2016 | 76159 | Class II | Terminated | Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 | 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. | accessdata.fda.gov |
| May 9, 2016 | 74113 | Class II | Terminated | 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 | The device was found to have bacterial contamination. | accessdata.fda.gov |
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Updated April 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.