IMMCO DIAGNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30153765453015376545IMMCO DIAGNOSTICS, INC.1N2026-01-0110 Earhart Drive -- Williamsville NY US 14221
13153361315336IMMCO DIAGNOSTICS, INC.1N2020-04-2560 PINEVIEW DR. Amherst NY US 14228

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00845714000003IMMCO DIAGNOSTICS - Hep-2 Cells -Anti-Nuclear Antibody IFA Kit1-800-537-8378INFO@IMMCO.COM
00845714000010IMMCO DIAGNOSTICS - Hep-2 Cells -Anti-Nuclear Antibody IFA Kit1-800-537-8378INFO@IMMCO.COM
00845714000089IMMCO DIAGNOSTICS - COMVI III Mouse Liver/Kidney/Stomach IFA Kit1-800-537-8378INFO@IMMCO.COM
00845714000096IMMCO DIAGNOSTICS - COMVI III Mouse Liver/Kidney/Stomach IFA Kit1-800-537-8378info@immco.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2295001789880667K982898IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEMMOB1998-11-30
308451789880667K982898IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEMMOB1998-11-30
308451296087498K970177ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISAMID1997-06-11
308451931245737K964344IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KITMST1997-05-30
308451728102574K964341IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KITMST1997-05-30
308451338075195K960370THYROGLOBULIN ANTIBODY ELISAJZO1996-06-20
308451375876031K960369THYROID PEROXIDASE ANTIBODY ELISAJZO1996-06-20
308451871324922K943585ANTI-HISTONE ANIBODY TESTLJM1995-01-20
308451930852655K942272IGM RHEUMATOID FACTORDHR1994-09-26
308452063759086K933788ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TESTMID1995-03-07
308451095935897K933786ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TESTMID1995-03-07
308451061101223K933784ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST)MID1995-03-07
308451656311987K921658ANTI-DSDNA ANTIBODY TESTLSW1993-03-22
308451867073937K920386ANTI-ENA ANTIBODY TEST KITLLL1992-03-30
308451355056926K920385ANTI-ENA ANTIBODY TEST (SM)LLL1992-03-30
308451678987789K920384ANIT-ENA ANTIBODY TEST [SS-B (LA)]LLL1992-03-30
308451931419371K920383ANTI-ENA ANTIBODY TEST [SS-A (RO)]LLL1992-03-30
308451842655470K913360ANTI-RETICULIN ANTIBODY (ARA) TESTDBL1994-09-26
2295001842655470K913360ANTI-RETICULIN ANTIBODY (ARA) TESTDBL1994-09-26
308452038465295K912551ANTI-ENDOMYSIAL ANTIBODY TESTDBL1993-06-09
2295002038465295K912551ANTI-ENDOMYSIAL ANTIBODY TESTDBL1993-06-09
308451778211843K903314ANTI-SCI-70 ANTIBODY TESTLLL1990-08-14
308451045040990K895339ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TESTLLL1989-10-04
308451387078647K891099ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)DBL1989-03-22
2295001387078647K891099ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)DBL1989-03-22
308451256818702K891098ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)DBL1989-03-22
2295001256818702K891098ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)DBL1989-03-22
308451502682416K884400ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)DHN1988-11-04
2295001502682416K884400ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)DHN1988-11-04
308451457266065K883949ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)LKJ1988-10-27
2295001457266065K883949ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)LKJ1988-10-27
308451514016334K883915AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)DBL1988-10-19
2295001514016334K883915AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)DBL1988-10-19
2295002056567834K883883ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)LKJ1988-10-27
308452056567834K883883ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)LKJ1988-10-27
308451433789522K172745ImmuGlo HEp-2 Elite IFADHN2018-06-05
2295001433789522K172745ImmuGlo HEp-2 Elite IFADHN2018-06-05
308451575576815K172254Lyme B. burgdorferi (IgM) MarStripe TestLSR2017-10-23
2295001575576815K172254Lyme B. burgdorferi (IgM) MarStripe TestLSR2017-10-23
308451084440511K172078ImmuLisa Enhanced RNA POL III Antibody ELISANYO2018-03-30
308451493020094K163177ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAMST2017-07-28
308451464738472K163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISADBM2017-08-08
308451043257306K163095Lyme B. burgdorferi (IgG) MarStripe TestLSR2017-02-01
2295001043257306K163095Lyme B. burgdorferi (IgG) MarStripe TestLSR2017-02-01
308451209166634K162788ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISAMSV2017-06-19
308451621845661K151559ImmuLisa Enhanced Centromere Antibody ELISALJM2016-03-11
308451203274237K143736ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISADHR2015-09-23
2295001203274237K143736ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISADHR2015-09-23
308452013167966K142781ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISALLL2015-03-31
2295002013167966K142781ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISALLL2015-03-31
308451239658039K123713IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISAMVM2013-10-25
308451418740209K113143IMMULISA SCI-70 ANTIBODY ELISALLL2011-12-02
308451323895633K113020IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISASMID2012-10-25
308451692676915K101319IMMULISA DSDNA ANTIBODY ELISALRM2010-12-09
2295001692676915K101319IMMULISA DSDNA ANTIBODY ELISALRM2010-12-09
308451484795801K092601IMMULISA ANCA SCREEN ELISAMOB2010-10-07
2295001221901839K092600IMMULISA PR3 ANTIBODY ELISAMOB2010-10-07
308451221901839K092600IMMULISA PR3 ANTIBODY ELISAMOB2010-10-07
308451886337539K092599IMMULISA MPO ANTIBODY ELISAMOB2010-10-07
2295001886337539K092599IMMULISA MPO ANTIBODY ELISAMOB2010-10-07
308451971496356K091657IMMUNOSCAN CCPLUSNHX2009-11-19
308451741274183K091522IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISAMST2010-02-04
308451205633445K091520IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISAMVM2010-03-10
2295001205633445K091520IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISAMVM2010-03-10
308451908742373K071346IMMULISA INTRINSIC FACTOR ANTIBODY ELISALIG2007-09-24
308451737336178K060157IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFAMVM2006-05-25
2295001737336178K060157IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFAMVM2006-05-25
308451547942397K041102IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISALJM2004-10-26
308451008332270K040095IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISAMVM2004-03-05
308451838239329K032860IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)NBT2004-03-18
308451802460012K032850IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)NBT2004-03-18
308451506787395K032571IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISAMVM2003-12-24
308451913714494K030702IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISAMSV2003-09-09
308451449933923K030701IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISAMSV2003-09-09
308451164461412
308451422816694
308451717232542
308451819708501
308452005067540
308452038964328
308452045398563
2295001128385612
2295001164461412
2295001422816694
2295001717232542
2295001819708501
2295002005067540
2295002038964328
2295002045398563

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DBL101994-09-26
LLL92015-03-31
MVM72013-10-25
MOB72010-10-07
MID52012-10-25
DHN42018-06-05
LSR42017-10-23
MST42017-07-28
LKJ41988-10-27
MSV32017-06-19
LJM32016-03-11
DHR32015-09-23
LRM22010-12-09
NBT22004-03-18
JZO21996-06-20
NYO12018-03-30
DBM12017-08-08
NHX12009-11-19
LIG12007-09-24
LSW11993-03-22

PMN#

55 records. Showing 1-40. Next

GUDID#

189 records. Showing 1-40. Next