IMMY, Inc.
Norman, OK, US
IMMY, Inc. appears in FDA device records in Norman, OK. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to IMMY, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Immuno-Mycologics, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 26 510(k) clearances for IMMY, Inc. between 1979 and 2012. The busiest year on record is 1979, with 14. The most recent is 2012, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 14 |
| 1980 | 2 |
| 1981 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1988 | 2 |
| 2011 | 2 |
| 2012 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120946 | ALPHA CRYPTOCOCCAL ANTIGEN EIA | MDU | Substantially Equivalent | |
| K112422 | CRAG LATERAL FLOW ASSAY (LFA) | GMD | Substantially Equivalent | |
| K102286 | CRAG LATERAL FLOW ASSAY (CRAG LFA) | GMD | Substantially Equivalent | |
| K101407 | ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 | MIZ | Substantially Equivalent | |
| K883333 | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT | JTL | Substantially Equivalent | |
| K880029 | EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 | KFH | Substantially Equivalent | |
| K843286 | EI-CANDIDA ENZYME IMMUNOASSAY EI1001 | LRF | Substantially Equivalent | |
| K831918 | LA-STAPH IDENTIFICATION SYSTEM | JWX | Substantially Equivalent | |
| K830837 | LA-HISTO ANTIBODY SYSTEM #HL 1001 | GMJ | Substantially Equivalent | |
| K810510 | YA-CRYPTO ANTIBODY TUBE AGGLUTINATION | GMD | Substantially Equivalent | |
| K802427 | LA-SPORO ANTIBODY SYSTEM | GMA | Substantially Equivalent | |
| K800908 | CAPIK-CANDIDA ALBICANS IDENT. KIT. | JXB | Substantially Equivalent | |
| K791395 | ANTI-HISTOPLASMA SERUM #CF10025X | GMK | Substantially Equivalent | |
| K791394 | HISTOPLASMA MYCELIAL #CF10020X | GMJ | Substantially Equivalent | |
| K791393 | HISTOPLASMA YEAST ANTI #CF10021X | GMJ | Substantially Equivalent | |
| K791392 | ANTI-HISTOPLASMA SERUM #CF10026X | GMK | Substantially Equivalent | |
| K791390 | ANTI-BLASTOMYCES SERUM #CF10027X | GMK | Substantially Equivalent | |
| K791389 | COCCIDIOIDES ANTIGEN #CF10023X | GMI | Substantially Equivalent | |
| K791388 | ANTI-COCCIDIOIDES SERUM #CF10028X | GMH | Substantially Equivalent | |
| K791387 | ASPERGILLUS MYCELIAL ANTIGEN #CF10024X | JWT | Substantially Equivalent | |
| K791386 | ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM | KFG | Substantially Equivalent | |
| K791385 | NEGATIVE CONTROL SERUM FOR CF RO ID | GSN | Substantially Equivalent | |
| K791384 | FUNGAL IMMUNODIFFUSION KIT #ID1001 | GMJ | Substantially Equivalent | |
| K791383 | CANDIDA IMMUNODIFFUSION KIT #CA1001 | GMI | Substantially Equivalent | |
| K791382 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION | GMD | Substantially Equivalent | |
| K791381 | COCCIDIODES (COCCI) | GMG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1627497 | 1627497 | IMMY, Inc. | 2701 Corporate Centre Dr, NORMAN, OK 73069 US | 2026 | and 15 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LSHAntigen, Blastomyces Dermatitidis, Other
- GMIAntigen, Cf And / Or Id, Coccidioides Immitis
- JWTAntigen, Cf, Aspergillus Spp.
- MDUAntigen, Elisa, Cryptococcus
- GMGAntigen, Latex Agglutination, Coccidioides Immitis
- GMJAntigens, Histoplasma Capsulatum, All
- GMAAntisera, Fluorescent, Sporothrix Schenekii
- GMDAntisera, Latex Agglutination, Cryptococcus Neoformans
- LSIAntiserum, Blastomyces Dermatitidis, Other
- GSNAntiserum, Positive And Negative Febrile Antigen Control Serum
- KFGAntiserum, Positive Control, Aspergillus Spp.
- KFHAntiserum, Positive Control, Blastomyces Dermatitidis
- GMHAntiserum, Positive Control, Coccidioides Immitis
- GMKAntiserum, Positive Control, Histoplasma Capsulatum
- PIICandida Species Nucleic Acid Detection System
- LSGCandida Species, Antibody Detection
- LRFCandida Spp., Direct Antigen, Id
- QAACoccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- MJLEia, Blastomyces Dermatitidis
- MIZEnzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
- MIYEnzyme Linked Immunosorbent Assay, Coccidioides Immitis
- PPMGeneral Purpose Reagent
- JXBKit, Identification, Yeast
- JWXKit, Screening, Staphylococcus Aureus
- OHQMulti-Analyte Controls Unassayed
- JTLPlasma, Coagulase, Human, Horse And Rabbit
- JZPPlates, Ouchterlony Agar
- MVUReagents, Specific, Analyte
- KEWSlides, Microscope
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1984-2026 | 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 | Class II | Open, Classified | |
| Z-1389-2025 | 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. | Class II | Open, Classified | |
| Z-0545-2022 | 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 results are NOT affected. | Class II | Terminated | |
| Z-2301-2020 | 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 | False positive results due to potential contamination of reagent. | Class II | Terminated | |
| Z-2409-2018 | 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. | Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results | Class II | Terminated | |
| Z-1109-2017 | 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. | Class II | Terminated | |
| Z-2040-2016 | 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 | The device was found to have bacterial contamination. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain