ImmuGlo HEp-2 Elite IFA
IMMCO Diagnostics, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015376545 | 3015376545 | IMMCO DIAGNOSTICS, INC. | 1 | N | 2026-01-01 | 10 Earhart Drive -- Williamsville NY US 14221 |
| 1315336 | 1315336 | IMMCO DIAGNOSTICS, INC. | 1 | N | 2020-04-25 | 60 PINEVIEW DR. Amherst NY US 14228 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00845714000003 | IMMCO DIAGNOSTICS - Hep-2 Cells -Anti-Nuclear Antibody IFA Kit | 1-800-537-8378 | INFO@IMMCO.COM |
| 00845714000010 | IMMCO DIAGNOSTICS - Hep-2 Cells -Anti-Nuclear Antibody IFA Kit | 1-800-537-8378 | INFO@IMMCO.COM |
| 00845714000089 | IMMCO DIAGNOSTICS - COMVI III Mouse Liver/Kidney/Stomach IFA Kit | 1-800-537-8378 | INFO@IMMCO.COM |
| 00845714000096 | IMMCO DIAGNOSTICS - COMVI III Mouse Liver/Kidney/Stomach IFA Kit | 1-800-537-8378 | info@immco.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 229500 | 1789880667 | K982898 | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM | MOB | 1998-11-30 |
| 30845 | 1789880667 | K982898 | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM | MOB | 1998-11-30 |
| 30845 | 1296087498 | K970177 | ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA | MID | 1997-06-11 |
| 30845 | 1931245737 | K964344 | IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT | MST | 1997-05-30 |
| 30845 | 1728102574 | K964341 | IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT | MST | 1997-05-30 |
| 30845 | 1338075195 | K960370 | THYROGLOBULIN ANTIBODY ELISA | JZO | 1996-06-20 |
| 30845 | 1375876031 | K960369 | THYROID PEROXIDASE ANTIBODY ELISA | JZO | 1996-06-20 |
| 30845 | 1871324922 | K943585 | ANTI-HISTONE ANIBODY TEST | LJM | 1995-01-20 |
| 30845 | 1930852655 | K942272 | IGM RHEUMATOID FACTOR | DHR | 1994-09-26 |
| 30845 | 2063759086 | K933788 | ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST | MID | 1995-03-07 |
| 30845 | 1095935897 | K933786 | ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST | MID | 1995-03-07 |
| 30845 | 1061101223 | K933784 | ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST) | MID | 1995-03-07 |
| 30845 | 1656311987 | K921658 | ANTI-DSDNA ANTIBODY TEST | LSW | 1993-03-22 |
| 30845 | 1867073937 | K920386 | ANTI-ENA ANTIBODY TEST KIT | LLL | 1992-03-30 |
| 30845 | 1355056926 | K920385 | ANTI-ENA ANTIBODY TEST (SM) | LLL | 1992-03-30 |
| 30845 | 1678987789 | K920384 | ANIT-ENA ANTIBODY TEST [SS-B (LA)] | LLL | 1992-03-30 |
| 30845 | 1931419371 | K920383 | ANTI-ENA ANTIBODY TEST [SS-A (RO)] | LLL | 1992-03-30 |
| 30845 | 1842655470 | K913360 | ANTI-RETICULIN ANTIBODY (ARA) TEST | DBL | 1994-09-26 |
| 229500 | 1842655470 | K913360 | ANTI-RETICULIN ANTIBODY (ARA) TEST | DBL | 1994-09-26 |
| 30845 | 2038465295 | K912551 | ANTI-ENDOMYSIAL ANTIBODY TEST | DBL | 1993-06-09 |
| 229500 | 2038465295 | K912551 | ANTI-ENDOMYSIAL ANTIBODY TEST | DBL | 1993-06-09 |
| 30845 | 1778211843 | K903314 | ANTI-SCI-70 ANTIBODY TEST | LLL | 1990-08-14 |
| 30845 | 1045040990 | K895339 | ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST | LLL | 1989-10-04 |
| 30845 | 1387078647 | K891099 | ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) | DBL | 1989-03-22 |
| 229500 | 1387078647 | K891099 | ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) | DBL | 1989-03-22 |
| 30845 | 1256818702 | K891098 | ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) | DBL | 1989-03-22 |
| 229500 | 1256818702 | K891098 | ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) | DBL | 1989-03-22 |
| 30845 | 1502682416 | K884400 | ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) | DHN | 1988-11-04 |
| 229500 | 1502682416 | K884400 | ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) | DHN | 1988-11-04 |
| 30845 | 1457266065 | K883949 | ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT) | LKJ | 1988-10-27 |
| 229500 | 1457266065 | K883949 | ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT) | LKJ | 1988-10-27 |
| 30845 | 1514016334 | K883915 | AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) | DBL | 1988-10-19 |
| 229500 | 1514016334 | K883915 | AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) | DBL | 1988-10-19 |
| 229500 | 2056567834 | K883883 | ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) | LKJ | 1988-10-27 |
| 30845 | 2056567834 | K883883 | ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) | LKJ | 1988-10-27 |
| 30845 | 1433789522 | K172745 | ImmuGlo HEp-2 Elite IFA | DHN | 2018-06-05 |
| 229500 | 1433789522 | K172745 | ImmuGlo HEp-2 Elite IFA | DHN | 2018-06-05 |
| 30845 | 1575576815 | K172254 | Lyme B. burgdorferi (IgM) MarStripe Test | LSR | 2017-10-23 |
| 229500 | 1575576815 | K172254 | Lyme B. burgdorferi (IgM) MarStripe Test | LSR | 2017-10-23 |
| 30845 | 1084440511 | K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISA | NYO | 2018-03-30 |
| 30845 | 1493020094 | K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA | MST | 2017-07-28 |
| 30845 | 1464738472 | K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA | DBM | 2017-08-08 |
| 30845 | 1043257306 | K163095 | Lyme B. burgdorferi (IgG) MarStripe Test | LSR | 2017-02-01 |
| 229500 | 1043257306 | K163095 | Lyme B. burgdorferi (IgG) MarStripe Test | LSR | 2017-02-01 |
| 30845 | 1209166634 | K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA | MSV | 2017-06-19 |
| 30845 | 1621845661 | K151559 | ImmuLisa Enhanced Centromere Antibody ELISA | LJM | 2016-03-11 |
| 30845 | 1203274237 | K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA | DHR | 2015-09-23 |
| 229500 | 1203274237 | K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA | DHR | 2015-09-23 |
| 30845 | 2013167966 | K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA | LLL | 2015-03-31 |
| 229500 | 2013167966 | K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA | LLL | 2015-03-31 |
| 30845 | 1239658039 | K123713 | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA | MVM | 2013-10-25 |
| 30845 | 1418740209 | K113143 | IMMULISA SCI-70 ANTIBODY ELISA | LLL | 2011-12-02 |
| 30845 | 1323895633 | K113020 | IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS | MID | 2012-10-25 |
| 30845 | 1692676915 | K101319 | IMMULISA DSDNA ANTIBODY ELISA | LRM | 2010-12-09 |
| 229500 | 1692676915 | K101319 | IMMULISA DSDNA ANTIBODY ELISA | LRM | 2010-12-09 |
| 30845 | 1484795801 | K092601 | IMMULISA ANCA SCREEN ELISA | MOB | 2010-10-07 |
| 229500 | 1221901839 | K092600 | IMMULISA PR3 ANTIBODY ELISA | MOB | 2010-10-07 |
| 30845 | 1221901839 | K092600 | IMMULISA PR3 ANTIBODY ELISA | MOB | 2010-10-07 |
| 30845 | 1886337539 | K092599 | IMMULISA MPO ANTIBODY ELISA | MOB | 2010-10-07 |
| 229500 | 1886337539 | K092599 | IMMULISA MPO ANTIBODY ELISA | MOB | 2010-10-07 |
| 30845 | 1971496356 | K091657 | IMMUNOSCAN CCPLUS | NHX | 2009-11-19 |
| 30845 | 1741274183 | K091522 | IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA | MST | 2010-02-04 |
| 30845 | 1205633445 | K091520 | IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA | MVM | 2010-03-10 |
| 229500 | 1205633445 | K091520 | IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA | MVM | 2010-03-10 |
| 30845 | 1908742373 | K071346 | IMMULISA INTRINSIC FACTOR ANTIBODY ELISA | LIG | 2007-09-24 |
| 30845 | 1737336178 | K060157 | IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA | MVM | 2006-05-25 |
| 229500 | 1737336178 | K060157 | IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA | MVM | 2006-05-25 |
| 30845 | 1547942397 | K041102 | IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA | LJM | 2004-10-26 |
| 30845 | 1008332270 | K040095 | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA | MVM | 2004-03-05 |
| 30845 | 1838239329 | K032860 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) | NBT | 2004-03-18 |
| 30845 | 1802460012 | K032850 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) | NBT | 2004-03-18 |
| 30845 | 1506787395 | K032571 | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA | MVM | 2003-12-24 |
| 30845 | 1913714494 | K030702 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA | MSV | 2003-09-09 |
| 30845 | 1449933923 | K030701 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA | MSV | 2003-09-09 |
| 30845 | 1164461412 | ||||
| 30845 | 1422816694 | ||||
| 30845 | 1717232542 | ||||
| 30845 | 1819708501 | ||||
| 30845 | 2005067540 | ||||
| 30845 | 2038964328 | ||||
| 30845 | 2045398563 | ||||
| 229500 | 1128385612 | ||||
| 229500 | 1164461412 | ||||
| 229500 | 1422816694 | ||||
| 229500 | 1717232542 | ||||
| 229500 | 1819708501 | ||||
| 229500 | 2005067540 | ||||
| 229500 | 2038964328 | ||||
| 229500 | 2045398563 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DBL | 10 | 1994-09-26 |
| LLL | 9 | 2015-03-31 |
| MVM | 7 | 2013-10-25 |
| MOB | 7 | 2010-10-07 |
| MID | 5 | 2012-10-25 |
| DHN | 4 | 2018-06-05 |
| LSR | 4 | 2017-10-23 |
| MST | 4 | 2017-07-28 |
| LKJ | 4 | 1988-10-27 |
| MSV | 3 | 2017-06-19 |
| LJM | 3 | 2016-03-11 |
| DHR | 3 | 2015-09-23 |
| LRM | 2 | 2010-12-09 |
| NBT | 2 | 2004-03-18 |
| JZO | 2 | 1996-06-20 |
| NYO | 1 | 2018-03-30 |
| DBM | 1 | 2017-08-08 |
| NHX | 1 | 2009-11-19 |
| LIG | 1 | 2007-09-24 |
| LSW | 1 | 1993-03-22 |
IMMCO Diagnostics, Inc.
IMMCO Diagnostics, Inc.
IMMCO Diagnostics, Inc.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
IMMCO DIAGNOSTICS, INC.
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