FDA.reportPublic FDA data

IMMUNO CONCEPTS, NA, Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29187682918768IMMUNO CONCEPTS, NA, Ltd.1N2026-01-019825 Goethe Rd Ste 350 SACRAMENTO CA US 95827
30028106143002810614Immuno Concepts, NA, LTD.1N2020-04-252280 Springlake Road Suite 106 Dallas TX US 75234

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
388292032091086K992041RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11LJM1999-07-23
388291910339866K983924HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RODHN1998-12-18
388291051909910K974478IMMUNO CONCEPTS ANCA TEST SYSTEMSMOB1998-02-09
388291954835393K974463IMMUNO CONCEPTS ANCA TEST SYSTEMMOB1998-02-09
388291521583630K972145HEP-2000 FLUORESCENT ANA-RO TEST SYSTEMDHN1998-02-24
388291471746971K963275RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEMLLL1996-09-13
388291888339429K955605RELISA JO-1 ANTIBODY TEST SYSTEMLLL1996-04-19
388291140690559K955604RELISA SM/RNP ANTIBODY TEST SYSTEMLLL1996-04-19
388291587172805K955603RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEMLLL1996-04-19
388291205290688K955602RELSIA SCL-70 ANTIBODY TEST SYSTEMLLL1996-04-19
388291809232139K950979HEP-2000 COLORZYME ANA-RO TEST SYSTEMDHN1995-06-01
388291031567193K944096HEP-2000 FLUORESCENT ANA-RO TEST SYSTEMDHN1994-11-21
388291074177920K935129RELISA ENA ANTIBODY SCREENING TEST SYSTEMLLL1994-01-31
388291380786422K932225ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEMMID1993-07-06
388291831275676K912489COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYSLSE1991-07-24
388291145117829K912488FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYSLSE1991-07-24
388292071358422K911661ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEMMID1991-12-09
388291792012714K895708EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)LLM1989-12-11
388291154407531K895707EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)LLM1989-12-08
388292029250213K880886EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)LJN1988-08-30
388291162313499K880885EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)GNP1988-08-30
388291654279009K880884EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)LJN1988-08-30
388291058154630K880883EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)GNP1988-08-30
388291195747402K860644SS-A/SS-B AUTOANTIBODY TEST SYSTEMLLL1986-03-28
388291741061049K860428SM-RNP AUTOANTIBODY TEST SYSTEMLLL1986-05-15
388291302761655K843225COLORZYME NDNA TEST SYSTEMDHN1984-11-01
388291484703400K833148ENZYME ANA TEST SYSTEMLJM1983-11-21
388291413701256K810301CRITHIDIA LUCILIAE NATIVE DNA-IFA TESTDHN1981-02-25
388291396345476K803276ANA-IFA TEST SYSTEMDHN1981-01-26
388291048568475K180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsDBL2018-10-19
388291489307597K160265Image Navigator by Immuno ConceptsDHN2016-06-17
2156731489307597K160265Image Navigator by Immuno ConceptsDHN2016-06-17
388291875875189K030775AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUMLKJ2003-05-12
388291296549245K013432IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040GKTL2001-11-29
388291581588243K013285RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15MOB2001-11-14
388291123832011K013283RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16MOB2001-11-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DHN92016-06-17
LLL81996-09-13
MOB42001-11-14
LJM21999-07-23
MID21993-07-06
LSE21991-07-24
LLM21989-12-11
GNP21988-08-30
LJN21988-08-30
DBL12018-10-19
LKJ12003-05-12
KTL12001-11-29

PMN#