Immuno Concepts Inc

FDA Filings

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

FDA Registration(s)
Registration Number3002810614
FEI Number3002810614
NameImmuno Concepts, NA, LTD.
Owner & OperatorIMMUNO CONCEPTS, INC.
Contact Address9825 Goethe Road Suite 350
Sacramento CA 95827 US
Official Correspondent
  • ERIC S HOY, PH.D.
  • x-916-3632649-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2280 Springlake Road Suite 106
Dallas, TX 75234 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number2918768
FEI Number2918768
NameIMMUNO CONCEPTS, NA, Ltd.
Owner & OperatorIMMUNO CONCEPTS, INC.
Contact Address9825 Goethe Road Suite 350
Sacramento CA 95827 US
Official Correspondent
  • ERIC S HOY, PH.D.
  • x-916-3632649-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9825 Goethe Rd Ste 350
SACRAMENTO, CA 95827 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent ANA-Ro Test System 2075B (1)2024-03-06
IMMUNO CONCEPTS INC
Fluorescent ANA Test System 2040CS2024-03-06
IMMUNO CONCEPTS INC
Histofluor® IgG Fluorescent Antibody Test System 12009-10 (1)2024-03-06
IMMUNO CONCEPTS INC
Histofluor® IgA Fluorescent Antibody Test System 12021-01 (1)2023-02-27
IMMUNO CONCEPTS INC
Fluorescent ANA Test System 8311.22022-12-14
IMMUNO CONCEPTS INC
Image Navigator® IN2202022-09-16
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent ANA-Ro Test System 8303-Ro2022-08-17
IMMUNO CONCEPTS INC
Histofluor® IgA Fluorescent Antibody Test System 12009-01 (1)2022-04-20
IMMUNO CONCEPTS INC
Image Navigator® IN1102021-11-05
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent w/cs ANA-Ro Test System 2280B-Ro2021-05-06
IMMUNO CONCEPTS INC
HEp-2 Fluorescent w/cs ANA Test System 2280B2021-05-06
IMMUNO CONCEPTS INC
HEp-2 Fluorescent w/cs ANA Test System 2140B2021-05-06
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent ANA-Ro Test System 2140B-Ro2021-05-04
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12075-02 (1)2021-02-17
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12080-032020-10-22
IMMUNO CONCEPTS INC
ANCA Test System 102100-112020-07-20
IMMUNO CONCEPTS INC
FITC Quality Control Slide ™ 1900 (1)2020-01-20
IMMUNO CONCEPTS INC
HEp-2000® Colorzyme® ANA-Ro Test System 4075-Ro (1)2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® Colorzyme® ANA-Ro Test System 4040-Ro2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® Colorzyme® ANA-Ro Test System 4000-18-Ro2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® Colorzyme® ANA-Ro Test System 4000-14-Ro2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent ANA-Ro Test System 2420CS-Ro2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent ANA-Ro Test System 2280G-Ro2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent ANA-Ro Test System 2280CS-Ro2019-11-14
IMMUNO CONCEPTS INC
Fluorescent nDNA Test System 2200-Ro2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent ANA-Ro Test System 2200G-Ro2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent ANA-Ro Test System 2200G-14-Ro2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® Fluorescent ANA-Ro Test System 2200-14-Ro2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® Fluorescent ANA-Ro Test System 2100-Ro2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent ANA-Ro Test System 2075G-Ro (1)2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent ANA-Ro Test System 2014-Ro (10)2019-11-14
IMMUNO CONCEPTS INC
Fluorescent ANA Test System 2014 (10)2019-11-14
IMMUNO CONCEPTS INC
Fluorescent ANA Test System 2013 (20)2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® Fluorescent ANA-Ro Test System 20100 (10)2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® Fluorescent ANA-Ro Test System 2004-Ro2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent ANA-Ro Test System 2004G-21-Ro2019-11-14
IMMUNO CONCEPTS INC
Fluorescent nDNA Test System 2004-142019-11-14
IMMUNO CONCEPTS INC
HEp-2000® Fluorescent ANA-Ro Test System 2002-14-Ro2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent ANA-Ro Test System 2000G-18-Ro2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® IgG Fluorescent ANA-Ro Test System 2000CS-18-Ro2019-11-14
IMMUNO CONCEPTS INC
Fluorescent ANA Test System 2000-142019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12800-022019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12400-042019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12262-02 (1)2019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12261-02R (1)2019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12261-02 (1)2019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12160-052019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12160-04R2019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12160-032019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12040-04R2019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12040-022019-11-14
IMMUNO CONCEPTS INC
Histofluor® Primate Esophagus Autoantibody Fluorescent Test System 12040-012019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12022-02R (1)2019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12008-05 (10)2019-11-14
IMMUNO CONCEPTS INC
Histofluor® Primate Esophagus Autoantibody Fluorescent Test System 12008-01 (10)2019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12004-04 (10)2019-11-14
IMMUNO CONCEPTS INC
Histofluor® Rodent LKS Fluorescent Antibody Test System 12004-02 (10)2019-11-14
IMMUNO CONCEPTS INC
ANCA-L Test System 10700L-112019-11-14
IMMUNO CONCEPTS INC
ANCA Test System 10700-122019-11-14
IMMUNO CONCEPTS INC
IMMUNO CONCEPTS Substrate Slide Test Systems 1042 Bulk2019-11-14
IMMUNO CONCEPTS INC
ANCA-L Test System 10350L-112019-11-14
IMMUNO CONCEPTS INC
ANCA Test System 10350-122019-11-14
IMMUNO CONCEPTS INC
ANCA-L Test System 10140L-112019-11-14
IMMUNO CONCEPTS INC
ANCA Test System 10100 (1)2019-11-14
IMMUNO CONCEPTS INC
ANCA Test System 10070-122019-11-14
IMMUNO CONCEPTS INC
ANCA Test System 10070-112019-11-14
IMMUNO CONCEPTS INC
ANCA Test System 10009-11 (1)2019-11-14
IMMUNO CONCEPTS INC
Fluorescent nDNA Test System 8250.12019-11-14
IMMUNO CONCEPTS INC
Fluorescent ANA Test System 8121.12019-11-14
IMMUNO CONCEPTS INC
AUTO I.D.® SSA/Ro and SSB/La Autoantibody Test System 7003 (1)2019-11-14
IMMUNO CONCEPTS INC
AUTO I.D.® SSA/Ro and SSB/La Autoantibody Test System 7001 (1)2019-11-14
IMMUNO CONCEPTS INC
AUTO I.D.® SSA/Ro and SSB/La Autoantibody Test System 6004 (1)2019-11-14
IMMUNO CONCEPTS INC
AUTO I.D.® Sm/RNP Autoantibody Test System 6002 (1)2019-11-14
IMMUNO CONCEPTS INC
AUTO I.D.® Sm/RNP Autoantibody Test System 6001 (1)2019-11-14
IMMUNO CONCEPTS INC
IgG Anti-nDNA Fluorescent Test System 3040G2019-11-14
IMMUNO CONCEPTS INC
Fluorescent nDNA Test System 3026 (1)2019-11-14
IMMUNO CONCEPTS INC
Fluorescent nDNA Test System 3021 (1)2019-11-14
IMMUNO CONCEPTS INC
IgG Anti-nDNA Fluorescent Test System 3005G2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® Fluorescent ANA-Ro Test System 2029 (1)2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® Fluorescent ANA-Ro Test System 2027 (1)2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® Fluorescent ANA-Ro Test System 2023 (2)2019-11-14
IMMUNO CONCEPTS INC
IMMUNO CONCEPTS Substrate Slide Test Systems 1042 (1)2019-11-14
IMMUNO CONCEPTS INC
HEp-2000® Fluorescent ANA-Ro Test System 84002019-11-14
IMMUNO CONCEPTS INC
Fluorescent ANA Test System 83112019-11-14
IMMUNO CONCEPTS INC
ANCA Test System 83092019-11-14
IMMUNO CONCEPTS INC
Fluorescent nDNA Test System 82992019-11-14
IMMUNO CONCEPTS INC
IgG Anti-nDNA Fluorescent Test System 82872019-11-14
IMMUNO CONCEPTS INC
IgG Anti-nDNA Fluorescent Test System 82842019-11-14
IMMUNO CONCEPTS INC
Fluorescent nDNA Test System 82682019-11-14
IMMUNO CONCEPTS INC
Fluorescent ANA Test System 82612019-11-14
IMMUNO CONCEPTS INC
IgG Anti-nDNA Fluorescent Test System 81962019-11-14
IMMUNO CONCEPTS INC
RELISA® Cardiolipin IgG & IgM Antibody Test 81922019-11-14
IMMUNO CONCEPTS INC
Colorzyme® nDNA Test System 52002019-11-14
IMMUNO CONCEPTS INC
Colorzyme® nDNA Test System 50052019-11-14
IMMUNO CONCEPTS INC
Colorzyme® ANA Test System 42002019-11-14
IMMUNO CONCEPTS INC
Fluorescent nDNA Test System 30012019-11-14
IMMUNO CONCEPTS INC
Fluorescent ANA Test System 21002019-11-14
IMMUNO CONCEPTS INC
Fluorescent ANA Test System 20052019-11-14
IMMUNO CONCEPTS INC
Fluorescent ANA Test System 5002019-11-14
IMMUNO CONCEPTS INC
Fluorescent ANA Test System 1002019-11-14
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
Histofluor? Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts2019-09-23
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
Histofluor? Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts2019-09-23
Immuno Concepts, NA, LTD. [IMMUNO CONCEPTS, INC.]
Image Navigator by Immuno Concepts2016-06-27
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
Image Navigator by Immuno Concepts2016-06-27
Immuno Concepts, NA, LTD. [IMMUNO CONCEPTS, INC.]
Image Navigator by Immuno Concepts2016-06-27
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
Image Navigator by Immuno Concepts2016-06-27
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
RELISA ANA Screening Test2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
HEp-2000 Colorzyme (SSA Confirm)2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
ANCA Ethanol Fluorescent2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
ANCA Formalin Fluorescent2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
HEP-2000 Fluorescent (SSA Confirm)2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
RELISA ENA Single Well Screen2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
RELISA Jo-12007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
RELISA Sm/RNP2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
RELISA SSA/SSB2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
RELISA Scl-702007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
HEp-2000 Colorzyme ANA-Ro2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
HEp-2000 Fluorescent ANA-Ro2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
RELISA ENA Multiparameter2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
RELISA Cardiolipin Antibody Screen2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
EBV-EA Colorzyme2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
EBV-EA Fluorescet2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
RELISA Cardiolipin IgG & IgM Test2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
EBNA Fluorescent2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
EBNA Colorzyme2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
EBV-VCA IgM Fluorescent2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
EBV-VCA IgG Colorzyme2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
EBV-VCA IgM Colorzyme2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
EBV-VCA IgG Fluorescent2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
AUTO ID SSA/SSB Autoantibody System2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
AUTO ID Sm/RNP Autoantibody Test Sy2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
Colorzyme nDNA Test System2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
Colorzyme ANA Test System2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
AUTO ID Optional Controls2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
IgG Anti-nDNA Fluorescent Test2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
RELISA MPO ANCA2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
RELISA PR3 ANCA2007-12-22
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
Fluorescent nDNA Test System2007-12-19
IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]
Fluorescent ANA Test System2007-12-19
IMMUNO CONCEPTS, INC.
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G2001-11-29
IMMUNO CONCEPTS, INC.
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-152001-11-14
IMMUNO CONCEPTS, INC.
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-162001-11-14
IMMUNO CONCEPTS, INC.
RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-111999-07-23
IMMUNO CONCEPTS, INC.
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO1998-12-18
IMMUNO CONCEPTS, INC.
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM1998-02-24
IMMUNO CONCEPTS, INC.
IMMUNO CONCEPTS ANCA TEST SYSTEMS1998-02-09
IMMUNO CONCEPTS, INC.
IMMUNO CONCEPTS ANCA TEST SYSTEM1998-02-09
IMMUNO CONCEPTS, INC.
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM1996-09-13
IMMUNO CONCEPTS, INC.
RELISA JO-1 ANTIBODY TEST SYSTEM1996-04-19
IMMUNO CONCEPTS, INC.
RELISA SM/RNP ANTIBODY TEST SYSTEM1996-04-19
IMMUNO CONCEPTS, INC.
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM1996-04-19
IMMUNO CONCEPTS, INC.
RELSIA SCL-70 ANTIBODY TEST SYSTEM1996-04-19
IMMUNO CONCEPTS, INC.
HEP-2000 COLORZYME ANA-RO TEST SYSTEM1995-06-01
IMMUNO CONCEPTS, INC.
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM1994-11-21
IMMUNO CONCEPTS, INC.
RELISA ENA ANTIBODY SCREENING TEST SYSTEM1994-01-31
IMMUNO CONCEPTS, INC.
ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM1993-07-06
IMMUNO CONCEPTS, INC.
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM1991-12-09
IMMUNO CONCEPTS, INC.
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS1991-07-24
IMMUNO CONCEPTS, INC.
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS1991-07-24
IMMUNO CONCEPTS, INC.
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)1989-12-11
IMMUNO CONCEPTS, INC.
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)1989-12-08
IMMUNO CONCEPTS, INC.
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)1989-07-25
IMMUNO CONCEPTS, INC.
CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)1989-07-14
IMMUNO CONCEPTS, INC.
CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)1989-07-14
IMMUNO CONCEPTS, INC.
CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST)1989-07-14
IMMUNO CONCEPTS, INC.
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)1988-08-30
IMMUNO CONCEPTS, INC.
EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)1988-08-30
IMMUNO CONCEPTS, INC.
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)1988-08-30
IMMUNO CONCEPTS, INC.
EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)1988-08-30
IMMUNO CONCEPTS, INC.
SM-RNP AUTOANTIBODY TEST SYSTEM1986-05-15
IMMUNO CONCEPTS, INC.
SS-A/SS-B AUTOANTIBODY TEST SYSTEM1986-03-28
IMMUNO CONCEPTS, INC.
COLORZYME NDNA TEST SYSTEM1984-11-01
IMMUNO CONCEPTS, INC.
ENZYME ANA TEST SYSTEM1983-11-21
IMMUNO CONCEPTS, INC.
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST1981-02-25
IMMUNO CONCEPTS, INC.
ANA-IFA TEST SYSTEM1981-01-26

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