Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1627497

FEI Number

1627497

Entity Name

IMMY, Inc.

City/State/Country

NORMAN, OK, US

Establishment Address

2701 Corporate Centre Dr, NORMAN, OK 73069, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IMMUNO-MYCOLOGICS, INC. (Owner Number: 9916020)

Owner / Operator Contact Address

2701 Corporate Centre Drive, --, Norman, OK 73069, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K791392

PMA Number

N/A

All Registered 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 CR2003 - CrAg Lateral Flow Assay 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GMD	Antisera, Latex Agglutination, Cryptococcus Neoformans	Microbiology	Class 2	866.3165	1979-11-21
GMD	Antisera, Latex Agglutination, Cryptococcus Neoformans	Microbiology	Class 2	866.3165	2007-11-27
MDU	Antigen, Elisa, Cryptococcus	Microbiology	Class 2	866.3165	2001-04-14
KFG	Antiserum, Positive Control, Aspergillus Spp.	Microbiology	Class 1	866.3040	1979-11-21
LSG	Candida Species, Antibody Detection	Microbiology	Class 2	866.3165	2005-09-28
GMI	Antigen, Cf And / Or Id, Coccidioides Immitis	Microbiology	Class 2	866.3135	2012-11-16
GMA	Antisera, Fluorescent, Sporothrix Schenekii	Microbiology	Class 1	866.3680	2005-08-22
GMI	Antigen, Cf And / Or Id, Coccidioides Immitis	Microbiology	Class 2	866.3135	2005-08-22
GMJ	Antigens, Histoplasma Capsulatum, All	Microbiology	Class 2	866.3320	1979-11-21
MJL	Eia, Blastomyces Dermatitidis	Microbiology	Class 2	866.3060	2005-07-06
QAA	Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens	Microbiology	Class 2	866.3376	2026-06-17
GMH	Antiserum, Positive Control, Coccidioides Immitis	Microbiology	Class 2	866.3135	1979-11-21
GMG	Antigen, Latex Agglutination, Coccidioides Immitis	Microbiology	Class 2	866.3135	2005-08-22
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2006-06-16
GMD	Antisera, Latex Agglutination, Cryptococcus Neoformans	Microbiology	Class 2	866.3165	2012-11-16
LSI	Antiserum, Blastomyces Dermatitidis, Other	Microbiology	Class 2	866.3060	2010-10-08
GMJ	Antigens, Histoplasma Capsulatum, All	Microbiology	Class 2	866.3320	1979-11-21
GMK	Antiserum, Positive Control, Histoplasma Capsulatum	Microbiology	Class 2	866.3320	1979-11-21
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2020-09-14
GSN	Antiserum, Positive And Negative Febrile Antigen Control Serum	Microbiology	Class 2	866.3085	2005-08-22
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2014-01-14
KFG	Antiserum, Positive Control, Aspergillus Spp.	Microbiology	Class 1	866.3040	2012-11-16
GMJ	Antigens, Histoplasma Capsulatum, All	Microbiology	Class 2	866.3320	2012-11-16
GMD	Antisera, Latex Agglutination, Cryptococcus Neoformans	Microbiology	Class 2	866.3165	2011-07-27
MIZ	Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum	Microbiology	Class 2	866.3320	2011-07-27
GMJ	Antigens, Histoplasma Capsulatum, All	Microbiology	Class 2	866.3320	2012-11-16
LSH	Antigen, Blastomyces Dermatitidis, Other	Microbiology	Class 2	866.3060	2010-10-08
PII	Candida Species Nucleic Acid Detection System	Microbiology	Class 2	866.3960	2026-06-05
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2014-08-07
MIY	Enzyme Linked Immunosorbent Assay, Coccidioides Immitis	Microbiology	Class 2	866.3135	2005-05-19
JZP	Plates, Ouchterlony Agar	Immunology	Class 1	866.4600	2005-08-22
GMK	Antiserum, Positive Control, Histoplasma Capsulatum	Microbiology	Class 2	866.3320	2012-11-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IMMUNO-MYCOLOGICS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K791383	Immuno-Mycologics, Inc.	CANDIDA IMMUNODIFFUSION KIT #CA1001	1979-08-16
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1627497. Last updated year: 2026. Please use registration number 1627497 when referencing this establishment in official correspondence.