FDA Registration
Active
🇺🇸 United States
IMMY, Inc.
Reg #: 1627497
·
FEI: 1627497
·
Expires 2026
Products
25
Proprietary Names
115
Establishment Types
3
Classifications
25
Registration Details
- Registration Name
- IMMY, Inc.
- Registration Number
- 1627497
- FEI Number
- 1627497
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2701 Corporate Centre Dr
- City
- NORMAN
- State
- OK
- ZIP
- 73069
- Country
- US
Regulatory Submissions
- 510(k) Number
- K810510
Owner / Operator
- Firm Name
- IMMUNO-MYCOLOGICS, INC.
- Operator Number
- 9916020
- Address
- 2701 Corporate Centre Drive, --
- City
- Norman
- State
- OK
- Postal Code
- 73069
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antisera, Latex Agglutination, Cryptococcus Neoformans | GMD | Class 2 | Microbiology | No | 1979-11-21 |
| Antigen, Elisa, Cryptococcus | MDU | Class 2 | Microbiology | No | 2001-04-14 |
| Antiserum, Positive Control, Aspergillus Spp. | KFG | Class 1 | Microbiology | No | 1979-11-21 |
| Candida Species, Antibody Detection | LSG | Class 2 | Microbiology | No | 2005-09-28 |
| Antigen, Cf And / Or Id, Coccidioides Immitis | GMI | Class 2 | Microbiology | No | 2012-11-16 |
| Antisera, Fluorescent, Sporothrix Schenekii | GMA | Class 1 | Microbiology | No | 2005-08-22 |
| Antigens, Histoplasma Capsulatum, All | GMJ | Class 2 | Microbiology | No | 1979-11-21 |
| Eia, Blastomyces Dermatitidis | MJL | Class 2 | Microbiology | No | 2005-07-06 |
| Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens | QAA | Class 2 | Microbiology | No | 2026-06-17 |
| Antiserum, Positive Control, Coccidioides Immitis | GMH | Class 2 | Microbiology | No | 1979-11-21 |
| Antigen, Latex Agglutination, Coccidioides Immitis | GMG | Class 2 | Microbiology | No | 2005-08-22 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2006-06-16 |
| Antiserum, Blastomyces Dermatitidis, Other | LSI | Class 2 | Microbiology | No | 2010-10-08 |
| Antiserum, Positive Control, Histoplasma Capsulatum | GMK | Class 2 | Microbiology | No | 1979-11-21 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2020-09-14 |
| Antiserum, Positive And Negative Febrile Antigen Control Serum | GSN | Class 2 | Microbiology | No | 2005-08-22 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2014-01-14 |
| Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum | MIZ | Class 2 | Microbiology | No | 2011-07-27 |
| Antigen, Blastomyces Dermatitidis, Other | LSH | Class 2 | Microbiology | No | 2010-10-08 |
| Candida Species Nucleic Acid Detection System | PII | Class 2 | Microbiology | No | 2026-06-05 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2014-08-07 |
| Enzyme Linked Immunosorbent Assay, Coccidioides Immitis | MIY | Class 2 | Microbiology | No | 2005-05-19 |
| Plates, Ouchterlony Agar | JZP | Class 1 | Immunology | No | 2005-08-22 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2004-08-23 |
| Antigen, Cf, Aspergillus Spp. | JWT | Class 1 | Microbiology | No | 2012-11-16 |
Proprietary Names
YA Cryptococcus
YA-CRYPTO CRYPTOCO
YA1001 - YA-Cryptococcus Antibody System
Cryptococcus Latex Kit
CR1003 - Latex-Cryptococcus Antigen Detection System
CR1004 - Latex-Cryptococcus Antigen Detection System
ALPHA Cryptococcal Antigen enzyme immunoassay
OMEGA ASPERGILLUS FU
Antibodies to Aspergillus
A40110 - Aspergillus ID Positive Control
A80110 - A. Fumigatus ID Positive Control
AE0110 - A. Niger ID Positive Control
AA0110 - A. Flavus ID Positive Control
AG0110 - A. Terreus ID Positive Control
C50110 - Candida ID Antigen
C60110 - Candida ID Positive Control
C10150-M - Coccidioides CF Antigen
QDXC90 - Coccidioides CF Antigen
C10150 - Coccidioides CF Antigen Dilute
LA-SPORO ANTIBODY SYSTEM
SL1001 - LA-Sporothrix Antibody System
CANDIDA IMMUNODIFFUSION (ID) KIT
CA1001 - ID Candida Antibody System
FUNGAL IMMUNODIFFUSION (ID) KIT
LA-HISTO
ID1001 - ID Fungal Antibody System
OMEGA BLASTOMYCES
BTA101 - OMEGA Blastomyces Total Antibody EIA
PneumID
Antibodies to Coccidioides
CD0110 - Coccidioides IDTP Positive Control
C40110 - Coccidioides IDCF Positive Control
COCCI LA KIT
CL1001 - LA-Coccidioides Antibody System
MycoDDR PrepBlue Digestion and Decontamination Reagents
MycoDDR Trident Digestion and Decontamination Reagents
DE0010 - Pronase
EIABU3 - EIA Reagents
CR2003 - CrAg Lateral Flow Assay
CRSQ25 - CrAg SQ Lateral Flow Assay (CrAg SQ LFA)
CR2025 - CrAg Lateral Flow Assay
Blastomyces ID Positive Control
B40110 - Blastomyces ID Positive Control
Histoplasma Antigen
H50110 - Histoplasma ID Antigen
HL1001 - LA-Histoplasma Antibody System
Antibodies to Histoplasma
H60110 - Histoplasma ID Positive Control
sona LFA Cube Reader
NEGATIVE CONTROL SERUM FOR CF OR ID
N80110 - Negative Control
Fungal Antigen Negative Control
Histoplasma Antigen Positive Control
A20110 - Aspergillus CF Positive Control
QDXH90 - Histoplasma Yeast CF Antigen
H30150-M - Histoplasma Yeast CF Antigen
H30150 - Histoplasma Yeast CF Antigen Dilute
CrAg Lateral Flow Assay
Cryptococcal Antigen Lateral Flow Assay
CrAg LFA
HGM201 - clarus Histoplasma GM EIA
ALPHA Histoplasma EIA Test Kit
ALPHA Histoplasma Antigen EIA
ALPHA Histoplasma Antigen Enzyme Immunoassay
HAG102 - ALPHA Histoplasma Antigen EIA
QDXH70 - Histoplasma Mycelial CF Antigen
H10150-M - Histoplasma Mycelial CF Antigen
H10150 - Histoplasma Mycelial CF Antigen Dilute
B10150-M - Blastomyces CF Antigen
QDXB50 - Blastomyces CF Antigen
Blastomyces ID Antigen
B10150 - Blastomyces CF Antigen Dilute
B30110 - Blastomyces ID Antigen
CandID
AurisID
BioFuse (TM)
OMEGA COCCIDIOIDES ANTIBODY EIA
Sona Coccidioides Antibody LFA (CTA2003)
CAB102 - OMEGA Coccidioides Antibody EIA
IMMUNODIFFUSION (ID) PLATES
ID1019 - ID Plates, 4 Series, Cleargel
ID1029 - ID Plates, 4 Series, Agarose
ID1039 - ID Plates, Large Well 4 Series, Cleargel
CA1019 - ID Plates, Single Series, Cleargel
H40110 - Histoplasma Yeast CF Positive Control
PI0110 - Paraccoi ID Antigen
PJ0110 - Paracocci ID Positive Control
HAG000 - 1000 EIA Unit Histplasma Antigen
SV10110 - S. virdis Antigen
PS10110 - Pigeon Serum Antigen
PS20110 - Goat Anti-Pigeon Serum
HGM000 - Histoplasma capsulatum Polysaccharide Antigen (100 ng/ml)
TC20110 - Goat Anti-T. candidus Serum
SR10110 - M. faeni Antigen
CB0050 - Cryptococcal Antigen External Positive Control
SV20110 - Goat Anti-S. virdis Serum
TV20110 - Goat Anti-T. vulgaris Serum
TC10110 - T. candidus Antigen
SR20110 - Goat Anti-M. faeni Serum
HGMDAB - Anti-Histoplasma Polysaccharide mAb-HRP Conjugate
TV10110 - T. vulgaris Antigen
HGMCAB - Anti-Histoplasma Polysaccharide Monoclonal Ab
B20110 - Blastomyces CF Positive Control
C20110 - Coccidioides CF Positive Control
Coccidioides Antigen
C30110 - Coccidioides IDCF Antigen
C70110 - Coccidioides IDTP Antigen
CI1001 - Coccidioides LA-ID Antibody System
A70110 - A. Fumigatus ID Antigen
AD0110 - A. Niger ID Antigen
AF0110 - A. Terreus ID Antigen
A90110 - A. Flavus ID Antigen
A30110 - Aspergillus ID Antigen
A10150 - Aspergillus CF Antigen Dilute
H20110 - Histoplasma Mycelial CF Positive Control
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility