Immy Inc

FDA Filings

This page includes the latest FDA filings for Immy Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1627497
FEI Number1627497
NameIMMY, Inc.
Owner & OperatorIMMUNO-MYCOLOGICS, INC.
Contact Address2701 Corporate Centre Drive --
Norman OK 73069 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2701 Corporate Centre Dr
NORMAN, OK 73069 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
clarus SARS-CoV-2 Total Antibody EIA2020-04-14
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
BioFuse (TM)2014-08-07
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
Histoplasma Antigen Positive Control2014-01-14
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
Fungal Antigen Negative Control2014-01-14
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
H20110 - Histoplasma Mycelial CF Positive Control2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
QDXH70 - Histoplasma Mycelial CF Antigen2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
H10150-M - Histoplasma Mycelial CF Antigen2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
H10150 - Histoplasma Mycelial CF Antigen Dilute2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
QDXH90 - Histoplasma Yeast CF Antigen2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
H30150-M - Histoplasma Yeast CF Antigen2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
H30150 - Histoplasma Yeast CF Antigen Dilute2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
H40110 - Histoplasma Yeast CF Positive Control2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
B20110 - Blastomyces CF Positive Control2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
QDXC90 - Coccidioides CF Antigen2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
C10150-M - Coccidioides CF Antigen2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
C10150 - Coccidioides CF Antigen Dilute2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
C20110 - Coccidioides CF Positive Control2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
AF0110 - A. Terreus ID Antigen2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
AD0110 - A. Niger ID Antigen2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
A90110 - A. Flavus ID Antigen2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
A70110 - A. Fumigatus ID Antigen2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
A30110 - Aspergillus ID Antigen2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
A10150 - Aspergillus CF Antigen Dilute2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
A20110 - Aspergillus CF Positive Control2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CR2003 - CrAg Lateral Flow Assay2012-11-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
Cryptococcal Antigen Lateral Flow Assay2011-07-27
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CrAg Lateral Flow Assay2011-07-27
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CrAg LFA2011-07-27
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CR2003 - CrAg Lateral Flow Assay2011-07-27
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
HGM201 - clarus Histoplasma GM EIA2011-07-27
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
HAG102 - ALPHA Histoplasma Antigen EIA2011-07-27
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
ALPHA Histoplasma EIA Test Kit2011-07-27
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
ALPHA Histoplasma Antigen Enzyme Immunoassay2011-07-27
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
ALPHA Histoplasma Antigen EIA2011-07-27
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
Blastomyces ID Positive Control2010-10-08
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
B40110 - Blastomyces ID Positive Control2010-10-08
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
QDXB50 - Blastomyces CF Antigen2010-10-08
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
Blastomyces ID Antigen2010-10-08
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
B30110 - Blastomyces ID Antigen2010-10-08
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
B10150-M - Blastomyces CF Antigen2010-10-08
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
B10150 - Blastomyces CF Antigen Dilute2010-10-08
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
Cryptococcus Latex Kit2007-11-27
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CR1004 - Latex-Cryptococcus Antigen Detection System2007-11-27
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CR1003 - Latex-Cryptococcus Antigen Detection System2007-11-27
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
MycoDDR Trident Digestion and Decontamination Reagents2006-06-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
MycoDDR PrepBlue Digestion and Decontamination Reagents2006-06-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
EIABU3 - EIA Reagents2006-06-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
DE0010 - Pronase2006-06-16
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
C60110 - Candida ID Positive Control2005-09-28
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
C50110 - Candida ID Antigen2005-09-28
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
SL1001 - LA-Sporothrix Antibody System2005-08-22
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
LA-SPORO ANTIBODY SYSTEM2005-08-22
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
NEGATIVE CONTROL SERUM FOR CF OR ID2005-08-22
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
N80110 - Negative Control2005-08-22
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CANDIDA IMMUNODIFFUSION (ID) KIT2005-08-22
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CA1001 - ID Candida Antibody System2005-08-22
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
COCCI LA KIT2005-08-22
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CL1001 - LA-Coccidioides Antibody System2005-08-22
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
IMMUNODIFFUSION (ID) PLATES2005-08-22
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
ID1039 - ID Plates, Large Well 4 Series, Cleargel2005-08-22
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
ID1029 - ID Plates, 4 Series, Agarose2005-08-22
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
ID1019 - ID Plates, 4 Series, Cleargel2005-08-22
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CA1019 - ID Plates, Single Series, Cleargel2005-08-22
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
OMEGA BLASTOMYCES2005-07-06
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
BTA101 - OMEGA Blastomyces Total Antibody EIA2005-07-06
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
Sona Coccidioides Antibody LFA (CTA2003)2005-05-19
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
OMEGA COCCIDIOIDES ANTIBODY EIA2005-05-19
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CAB102 - OMEGA Coccidioides Antibody EIA2005-05-19
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
TV20110 - Goat Anti-T. vulgaris Serum2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
TV10110 - T. vulgaris Antigen2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
TC20110 - Goat Anti-T. candidus Serum2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
TC10110 - T. candidus Antigen2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
SV20110 - Goat Anti-S. virdis Serum2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
SV10110 - S. virdis Antigen2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
SR20110 - Goat Anti-M. faeni Serum2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
SR10110 - M. faeni Antigen2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
PS20110 - Goat Anti-Pigeon Serum2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
PS10110 - Pigeon Serum Antigen2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
PJ0110 - Paracocci ID Positive Control2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
PI0110 - Paraccoi ID Antigen2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
HGMDAB - Anti-Histoplasma Polysaccharide mAb-HRP Conjugate2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
HGMCAB - Anti-Histoplasma Polysaccharide Monoclonal Ab2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
HGM000 - Histoplasma capsulatum Polysaccharide Antigen (100 ng/ml)2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
HAG000 - 1000 EIA Unit Histplasma Antigen2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CB0050 - Cryptococcal Antigen External Positive Control2004-08-23
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
ALPHA Cryptococcal Antigen enzyme immunoassay2001-04-14
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
Histoplasma Antigen1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
HL1001 - LA-Histoplasma Antibody System1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
H50110 - Histoplasma ID Antigen1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
YA1001 - YA-Cryptococcus Antibody System1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
YA-CRYPTO CRYPTOCO1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
YA Cryptococcus1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
LA-HISTO1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
ID1001 - ID Fungal Antibody System1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
FUNGAL IMMUNODIFFUSION (ID) KIT1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
OMEGA ASPERGILLUS FU1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
Antibodies to Aspergillus1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
AG0110 - A. Terreus ID Positive Control1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
AE0110 - A. Niger ID Positive Control1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
AA0110 - A. Flavus ID Positive Control1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
A80110 - A. Fumigatus ID Positive Control1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
A40110 - Aspergillus ID Positive Control1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
H60110 - Histoplasma ID Positive Control1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
Antibodies to Histoplasma1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
Coccidioides Antigen1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CI1001 - Coccidioides LA-ID Antibody System1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
C70110 - Coccidioides IDTP Antigen1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
C30110 - Coccidioides IDCF Antigen1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
CD0110 - Coccidioides IDTP Positive Control1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
C40110 - Coccidioides IDCF Positive Control1979-11-21
IMMY, Inc. [IMMUNO-MYCOLOGICS, INC.]
Antibodies to Coccidioides1979-11-21

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