MONOLISA ANTI-HBC IGM EIA
Bio-Rad Laboratories, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2016706 | 2016706 | Bio-Rad Laboratories Inc. | 1 | N | 2026-01-01 | 9500 Jeronimo Rd IRVINE CA US 92618 |
| 2915274 | 2915274 | Bio-Rad Laboratories, Inc. | 1 | Y | 2026-01-01 | 4000 Alfred Nobel Drive Hercules CA US 94547 |
| 3032705 | 3002701146 | BIO-RAD LABORATORIES, INC. | 1 | N | 2026-01-01 | 14620 NE North Woodinville Way Woodinville WA US 98072 |
| 3003756338 | 3003756338 | Bio-Rad Laboratories, Inc. | 1 | Y | 2026-01-01 | 2500 Atlas Rd Richmond CA US 94804 |
| 3006421415 | 3006421415 | Bio-Rad Laboratories (Singapore) Pte. Ltd. | 1 | N | 2026-01-01 | 1 Kaki Bukit View #03-01 & #05-01 Techview Singapore Central Singapore SG 415941 |
| 3007886270 | 3008272466 | BIO-RAD LABORATORIES, INC. | 1 | Y | 2026-01-01 | 8415 216th Street S.E. Woodinville WA US 98072 |
| 3010127294 | 3010127294 | Bio-Rad Laboratories Inc. | 1 | N | 2026-01-01 | 9 Holland Irvine CA US 92618 |
| 3032023483 | 3032023483 | Bio-Rad Laboratories (S) Pte Ltd | 1 | N | 2026-01-01 | 2 Pioneer Sector 1 #04-01/02 Singapore South West SG 628414 |
| 2950880 | 1000135116 | BIO-RAD LABORATORIES, INC. | 1 | N | 2020-04-25 | 5500 E 2nd St BENICIA CA US 94510 |
| 3022521 | 3022521 | BIO-RAD LABORATORIES, INC. | 1 | N | 2020-04-25 | 6565 185th Ave NE Redmond WA US 98052 |
| 3010581187 | 3010581187 | BIO-RAD LABORATORIES, INC. | 1 | N | 2020-04-25 | 5731 W Las Positas Blvd Pleasanton CA US 94588 |
| 3011826360 | 3011826360 | Bio-Rad Laboratories, Inc. | 1 | N | 2020-04-25 | 800 Alfred Nobel Drive Hercules CA US 94547 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03610522231072 | Liquichek - Liquichek Specialty Immunoassay Plus Control Level Low (A human serum assayed immunoassay control,) | +1(800)854-6737 | qsd.techservice@bio-rad.com |
| 03610522231089 | Liquichek - Liquichek Specialty Immunoassay Plus Control Level 1 (A human serum assayed immunoassay control.) | +1(800)854-6737 | qsd.techservice@bio-rad.com |
| 03610522231096 | Liquichek - Liquichek Specialty Immunoassay Plus Control Level 2 (A human serum assayed immunoassay control.) | +1(800)854-6737 | qsd.techservice@bio-rad.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 39662 | 1042014522 | P060034 | BIO RAD MONOLISA ANTI-HBC IGM EIA | SEI | 2007-05-31 |
| 39663 | 1042014522 | P060034 | BIO RAD MONOLISA ANTI-HBC IGM EIA | SEI | 2007-05-31 |
| 39662 | 1452972313 | P060031 | BIO-RAD MONOLISA ANTI-HBC EIA | SEI | 2007-04-27 |
| 39663 | 1452972313 | P060031 | BIO-RAD MONOLISA ANTI-HBC EIA | SEI | 2007-04-27 |
| 39662 | 2015886915 | P050048 | MONOLISA ANTI-HBS EIA | SEI | 2006-08-25 |
| 39663 | 2015886915 | P050048 | MONOLISA ANTI-HBS EIA | SEI | 2006-08-25 |
| 28024 | 2053557842 | K992741 | LYPHOCHEK ANEMIA CONTROL, MODEL 500 | JJY | 1999-11-09 |
| 154628 | 2053557842 | K992741 | LYPHOCHEK ANEMIA CONTROL, MODEL 500 | JJY | 1999-11-09 |
| 39662 | 1387723278 | K991975 | SERAQUEST EB NA IGG | LSE | 1999-11-02 |
| 39663 | 1387723278 | K991975 | SERAQUEST EB NA IGG | LSE | 1999-11-02 |
| 78768 | 1137125225 | K991127 | VARIANT II B-THALASSEMIA | JPD | 1999-06-10 |
| 203386 | 1137125225 | K991127 | VARIANT II B-THALASSEMIA | JPD | 1999-06-10 |
| 28024 | 1364132081 | K990928 | LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 | DIE | 1999-04-16 |
| 154628 | 1364132081 | K990928 | LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 | DIE | 1999-04-16 |
| 28024 | 1459426268 | K990888 | MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 | JJY | 1999-04-07 |
| 154628 | 1459426268 | K990888 | MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 | JJY | 1999-04-07 |
| 28024 | 1936237024 | K984594 | LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 | JJY | 1999-02-02 |
| 154628 | 1936237024 | K984594 | LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 | JJY | 1999-02-02 |
| 28024 | 1872248429 | K984225 | LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 | JJY | 1998-12-14 |
| 154628 | 1872248429 | K984225 | LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 | JJY | 1998-12-14 |
| 28024 | 1111975996 | K984071 | LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 | JJX | 1998-12-03 |
| 154628 | 1111975996 | K984071 | LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 | JJX | 1998-12-03 |
| 28024 | 1213652831 | K983032 | CBC-5D HEMATOLOGY CONTROL | JPK | 1999-02-17 |
| 154628 | 1213652831 | K983032 | CBC-5D HEMATOLOGY CONTROL | JPK | 1999-02-17 |
| 28018 | 1404789415 | K982898 | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM | MOB | 1998-11-30 |
| 78768 | 1404789415 | K982898 | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM | MOB | 1998-11-30 |
| 39662 | 1433515481 | K982485 | SERAQUEST CMV IGM | LFZ | 1999-01-13 |
| 39663 | 1433515481 | K982485 | SERAQUEST CMV IGM | LFZ | 1999-01-13 |
| 39662 | 2015902718 | K982281 | SERAQUEST RUBELLA IGM | LFX | 1998-10-16 |
| 39663 | 2015902718 | K982281 | SERAQUEST RUBELLA IGM | LFX | 1998-10-16 |
| 28024 | 1736094717 | K981532 | LYPHOCHEK IMMUNOASSAY PLUS CONTROL | JJY | 1998-05-12 |
| 154628 | 1736094717 | K981532 | LYPHOCHEK IMMUNOASSAY PLUS CONTROL | JJY | 1998-05-12 |
| 39662 | 1703448189 | K980059 | SERAQUEST MUMPS IGG | LJY | 1998-04-23 |
| 39663 | 1703448189 | K980059 | SERAQUEST MUMPS IGG | LJY | 1998-04-23 |
| 28024 | 1133774961 | K974613 | VIROTROL III | JJY | 1998-01-27 |
| 154628 | 1133774961 | K974613 | VIROTROL III | JJY | 1998-01-27 |
| 39662 | 1825327522 | K972295 | SERAQUEST VZV IGG | LFY | 1997-11-05 |
| 39663 | 1825327522 | K972295 | SERAQUEST VZV IGG | LFY | 1997-11-05 |
| 28024 | 1646257638 | K971952 | LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) | JJY | 1997-06-16 |
| 154628 | 1646257638 | K971952 | LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) | JJY | 1997-06-16 |
| 28024 | 1455298232 | K971405 | SPECIALITY URINE 1,2 | JJY | 1997-06-16 |
| 154628 | 1455298232 | K971405 | SPECIALITY URINE 1,2 | JJY | 1997-06-16 |
| 28024 | 2060856535 | K970666 | LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL | DIF | 1997-03-10 |
| 154628 | 2060856535 | K970666 | LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL | DIF | 1997-03-10 |
| 39662 | 1428681968 | K963282 | SERAQUEST HSV IGG | LGC | 1997-01-22 |
| 39663 | 1428681968 | K963282 | SERAQUEST HSV IGG | LGC | 1997-01-22 |
| 28024 | 1073958856 | K961828 | LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) | JJT | 1996-06-11 |
| 154628 | 1073958856 | K961828 | LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) | JJT | 1996-06-11 |
| 39662 | 1126875573 | K961053 | SERAQUEST RUBELLA IGG | LFX | 1996-09-04 |
| 39663 | 1126875573 | K961053 | SERAQUEST RUBELLA IGG | LFX | 1996-09-04 |
| 28024 | 1442479606 | K960987 | LIQUICHEK RHEUMATOID FACTOR CONTROL | DHR | 1996-06-04 |
| 154628 | 1442479606 | K960987 | LIQUICHEK RHEUMATOID FACTOR CONTROL | DHR | 1996-06-04 |
| 39662 | 2045175856 | K960092 | SERAQUEST TOXOPLASMA IGG | LGD | 1996-06-17 |
| 39663 | 2045175856 | K960092 | SERAQUEST TOXOPLASMA IGG | LGD | 1996-06-17 |
| 28018 | 1499580392 | K960091 | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | LRM | 1996-03-20 |
| 78768 | 1499580392 | K960091 | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | LRM | 1996-03-20 |
| 203386 | 1499580392 | K960091 | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | LRM | 1996-03-20 |
| 28024 | 1347507312 | K955153 | LYPHOCHEK BENZO/TCA CONTROL-SET B | DIF | 1996-02-05 |
| 154628 | 1347507312 | K955153 | LYPHOCHEK BENZO/TCA CONTROL-SET B | DIF | 1996-02-05 |
| 28024 | 1681847747 | K955024 | LIQUICHEK ETHANOL/AMMONIA CONTROL | JJY | 1995-11-28 |
| 154628 | 1681847747 | K955024 | LIQUICHEK ETHANOL/AMMONIA CONTROL | JJY | 1995-11-28 |
| 28018 | 1913699272 | K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT | LKJ | 1995-12-15 |
| 78768 | 1913699272 | K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT | LKJ | 1995-12-15 |
| 203386 | 1913699272 | K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT | LKJ | 1995-12-15 |
| 28024 | 1337969935 | K954298 | VIROTROL IV | JJY | 1995-11-01 |
| 154628 | 1337969935 | K954298 | VIROTROL IV | JJY | 1995-11-01 |
| 39662 | 1759906161 | K954191 | SERAQUEST CMV IGG | LFZ | 1996-02-23 |
| 39663 | 1759906161 | K954191 | SERAQUEST CMV IGG | LFZ | 1996-02-23 |
| 78768 | 1813563809 | K952817 | BIO-RAD URINARY 5-HIAA BY HPLC | CDA | 1995-08-01 |
| 28018 | 1722487835 | K952253 | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT | LLL | 1995-08-24 |
| 78768 | 1722487835 | K952253 | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT | LLL | 1995-08-24 |
| 203386 | 1722487835 | K952253 | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT | LLL | 1995-08-24 |
| 28018 | 1837375528 | K952183 | DIASTAT ANTI-THYROGLOBULIN KIT | JZO | 1995-06-30 |
| 78768 | 1837375528 | K952183 | DIASTAT ANTI-THYROGLOBULIN KIT | JZO | 1995-06-30 |
| 28018 | 1279150512 | K951850 | ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT | LJM | 1995-07-18 |
| 78768 | 1279150512 | K951850 | ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT | LJM | 1995-07-18 |
| 203386 | 1279150512 | K951850 | ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT | LJM | 1995-07-18 |
| 28018 | 1576581655 | K951798 | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT | LJM | 1995-07-17 |
| 78768 | 1576581655 | K951798 | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT | LJM | 1995-07-17 |
| 203386 | 1576581655 | K951798 | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT | LJM | 1995-07-17 |
| 78768 | 1580856511 | K942451 | BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM | LDM | 1994-11-10 |
| 28024 | 1274212649 | K942295 | VIROTROL TORCH | JJY | 1994-10-07 |
| 154628 | 1274212649 | K942295 | VIROTROL TORCH | JJY | 1994-10-07 |
| 28018 | 1545733741 | K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | LKO | 1994-04-20 |
| 78768 | 1545733741 | K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | LKO | 1994-04-20 |
| 203386 | 1545733741 | K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | LKO | 1994-04-20 |
| 28018 | 2038424964 | K940510 | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT | LKP | 1994-04-20 |
| 78768 | 2038424964 | K940510 | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT | LKP | 1994-04-20 |
| 203386 | 2038424964 | K940510 | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT | LKP | 1994-04-20 |
| 28024 | 1613573325 | K933317 | LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 | JJY | 1993-08-11 |
| 154628 | 1613573325 | K933317 | LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 | JJY | 1993-08-11 |
| 28018 | 1233568873 | K932419 | ANTI-SS-B/LA ANTIBODY TEST | LLL | 1993-08-05 |
| 78768 | 1233568873 | K932419 | ANTI-SS-B/LA ANTIBODY TEST | LLL | 1993-08-05 |
| 203386 | 1233568873 | K932419 | ANTI-SS-B/LA ANTIBODY TEST | LLL | 1993-08-05 |
| 28018 | 1801905803 | K931495 | ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT | LLL | 1993-07-16 |
| 78768 | 1801905803 | K931495 | ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT | LLL | 1993-07-16 |
| 203386 | 1801905803 | K931495 | ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT | LLL | 1993-07-16 |
| 28018 | 1794845285 | K921183 | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT | DBM | 1992-06-19 |
| 78768 | 1794845285 | K921183 | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT | DBM | 1992-06-19 |
| 39662 | 2032114725 | K911590 | IMMUNOWELL BORRELIA (LYME)TEST | LSR | 1991-12-20 |
| 39663 | 2032114725 | K911590 | IMMUNOWELL BORRELIA (LYME)TEST | LSR | 1991-12-20 |
| 28024 | 1751503501 | K911347 | LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL | JCM | 1991-06-10 |
| 154628 | 1751503501 | K911347 | LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL | JCM | 1991-06-10 |
| 28024 | 1087936611 | K910829 | LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2 | LAS | 1991-04-03 |
| 154628 | 1087936611 | K910829 | LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2 | LAS | 1991-04-03 |
| 28018 | 1524004920 | K905386 | DISTAT ANTI-DSDNA KIT | KTL | 1990-12-13 |
| 78768 | 1524004920 | K905386 | DISTAT ANTI-DSDNA KIT | KTL | 1990-12-13 |
| 28024 | 1669759452 | K903430 | LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 | JJT | 1990-08-23 |
| 154628 | 1669759452 | K903430 | LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 | JJT | 1990-08-23 |
| 28024 | 1186695852 | K902389 | TRI-COUNT 16 | JCN | 1990-08-22 |
| 154628 | 1186695852 | K902389 | TRI-COUNT 16 | JCN | 1990-08-22 |
| 78768 | 1905156398 | K894966 | PLASMA CATECHOLAMINES BY HPLC | CHQ | 1989-10-25 |
| 203386 | 1905156398 | K894966 | PLASMA CATECHOLAMINES BY HPLC | CHQ | 1989-10-25 |
| 78768 | 1014252576 | K890768 | PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT | LYF | 1989-03-21 |
| 39663 | 1686277221 | K890768 | PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT | LYF | 1989-03-21 |
| 28024 | 1404964752 | K890749 | CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE | JPK | 1989-02-27 |
| 154628 | 1404964752 | K890749 | CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE | JPK | 1989-02-27 |
| 28024 | 1098598253 | K881989 | LYPHOCHEK URINE TOXICOLOGY CONTROL | DIF | 1988-06-20 |
| 154628 | 1098598253 | K881989 | LYPHOCHEK URINE TOXICOLOGY CONTROL | DIF | 1988-06-20 |
| 28024 | 1421836945 | K880496 | LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1) | JJW | 1988-03-16 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JJY | 98 | 2017-01-10 |
| DIF | 34 | 2012-05-18 |
| DHN | 29 | 2003-01-17 |
| LCP | 23 | 2014-06-25 |
| JPK | 22 | 2010-01-29 |
| LKJ | 21 | 2012-07-09 |
| JJS | 12 | 2002-08-15 |
| LLL | 12 | 2000-04-05 |
| LSE | 10 | 2006-12-08 |
| JJW | 8 | 2007-04-25 |
| NHX | 7 | 2011-10-26 |
| JJX | 6 | 2013-01-09 |
| MXJ | 6 | 2012-06-22 |
| LFX | 6 | 2010-12-03 |
| MOB | 6 | 2010-06-03 |
| GGM | 6 | 2007-04-02 |
| GGN | 6 | 2004-02-27 |
| LKP | 6 | 2003-01-15 |
| LRM | 6 | 2000-09-11 |
| LJM | 6 | 1995-07-18 |
| LIP | 5 | 2017-05-11 |
| OMI | 5 | 2012-03-26 |
| OPL | 5 | 2011-08-23 |
| LSR | 4 | 2019-03-12 |
| MRG | 4 | 2018-06-22 |
| GKA | 4 | 2017-09-13 |
| PDJ | 4 | 2016-10-14 |
| PMN | 4 | 2016-05-10 |
| MST | 4 | 2013-12-05 |
| MID | 4 | 2013-10-21 |
| MVM | 4 | 2013-09-19 |
| LJN | 4 | 2012-11-02 |
| LOM | 4 | 2007-04-27 |
| JZO | 4 | 2002-05-02 |
| DIE | 4 | 2002-04-22 |
| LFZ | 4 | 1999-01-13 |
| JJT | 4 | 1996-06-11 |
| DBM | 4 | 1992-06-19 |
| DJG | 3 | 2006-04-21 |
| NVI | 3 | 2005-10-27 |
Bio-Rad Laboratories, Inc.
Bio-Rad Laboratories, Inc.
BIO-RAD LABORATORIES
Bio-Rad Laboratories, Inc.
Bio-Rad Laboratories, Inc.
BIO-RAD LABORATORIES
BIO-RAD LABORATORIES
Bio-Rad Laboratories, Inc.
Bio-Rad Laboratories, Inc.
BIO-RAD LABORATORIES
Bio-Rad Laboratories, Inc.
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Bio-Rad Laboratories, Inc.
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Bio-Rad Laboratories, Inc.
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Bio-Rad Laboratories, Inc.
BIO-RAD LABORATORIES
Bio-Rad Laboratories, Inc.
Bio-Rad Laboratories, Inc.
BIO-RAD LABORATORIES
Bio-Rad Laboratories, Inc.
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BIO-RAD LABORATORIES, INC.
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
BIO-RAD LABORATORIES, INC.
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
Bio-Rad Laboratories
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BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
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