MONOLISA ANTI-HBC IGM EIA
Bio-Rad Laboratories, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 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 |
| 3007886270 | 3008272466 | BIO-RAD LABORATORIES, INC. | 1 | Y | 2026-01-01 | 8415 216th St Se Woodinville WA US 98072 |
| 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 | |
|---|---|---|---|
| 00847661000778 | Lyphochek - Lyphochek Coagulation Control Level 1 (A human plasma coagulation control.) | +1(800)854-6737 | qsd.techservice@bio-rad.com |
| 00847661000785 | Lyphochek - Lyphochek Coagulation Control Level 2 (A human plasma coagulation control.) | +1(800)854-6737 | qsd.techservice@bio-rad.com |
| 00847661000792 | Lyphochek - Lyphochek Coagulation Control Level 3 (A human plasma coagulation control.) | +1(800)854-6737 | qsd.techservice@bio-rad.com |
| 00847661001027 | Lyphochek - Lyphochek Hemostasis Control Level 1 (A human plasma hemostasis control.) | +1(800)854-6737 | qsd.techservice@bio-rad.com |
| 03610522040131 | QXDx - QXDx Automated Droplet Generator | +1(800)224-6723 | diagcs@bio-rad.com |
| 03610522040148 | QXDx - QXDx Droplet Reader | +1(800)224-6723 | diagcs@bio-rad.com |
| 03610522991303 | QX600 - QX600Dx | +1(800)224-6723 | diagcs@bio-rad.com |
| 03610523006433 | QXDx - QXDx AutoDG Supermix Pack B | +1(800)224-6723 | diagcs@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 |
| 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 |
| 78768 | 1404789415 | K982898 | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM | MOB | 1998-11-30 |
| 28018 | 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 |
| 39662 | 1703448189 | K980059 | SERAQUEST MUMPS IGG | LJY | 1998-04-23 |
| 39663 | 1703448189 | K980059 | SERAQUEST MUMPS IGG | LJY | 1998-04-23 |
| 39662 | 1825327522 | K972295 | SERAQUEST VZV IGG | LFY | 1997-11-05 |
| 39663 | 1825327522 | K972295 | SERAQUEST VZV IGG | LFY | 1997-11-05 |
| 39662 | 1428681968 | K963282 | SERAQUEST HSV IGG | LGC | 1997-01-22 |
| 39663 | 1428681968 | K963282 | SERAQUEST HSV IGG | LGC | 1997-01-22 |
| 39662 | 1126875573 | K961053 | SERAQUEST RUBELLA IGG | LFX | 1996-09-04 |
| 39663 | 1126875573 | K961053 | SERAQUEST RUBELLA IGG | LFX | 1996-09-04 |
| 39662 | 2045175856 | K960092 | SERAQUEST TOXOPLASMA IGG | LGD | 1996-06-17 |
| 39663 | 2045175856 | K960092 | SERAQUEST TOXOPLASMA IGG | LGD | 1996-06-17 |
| 78768 | 1499580392 | K960091 | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | LRM | 1996-03-20 |
| 28018 | 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 |
| 78768 | 1913699272 | K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT | LKJ | 1995-12-15 |
| 28018 | 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 |
| 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 |
| 78768 | 1722487835 | K952253 | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT | LLL | 1995-08-24 |
| 28018 | 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 |
| 78768 | 1837375528 | K952183 | DIASTAT ANTI-THYROGLOBULIN KIT | JZO | 1995-06-30 |
| 28018 | 1837375528 | K952183 | DIASTAT ANTI-THYROGLOBULIN KIT | JZO | 1995-06-30 |
| 78768 | 1279150512 | K951850 | ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT | LJM | 1995-07-18 |
| 28018 | 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 |
| 78768 | 1576581655 | K951798 | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT | LJM | 1995-07-17 |
| 28018 | 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 |
| 78768 | 1545733741 | K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | LKO | 1994-04-20 |
| 28018 | 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 |
| 78768 | 2038424964 | K940510 | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT | LKP | 1994-04-20 |
| 28018 | 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 |
| 78768 | 1233568873 | K932419 | ANTI-SS-B/LA ANTIBODY TEST | LLL | 1993-08-05 |
| 28018 | 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 |
| 78768 | 1801905803 | K931495 | ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT | LLL | 1993-07-16 |
| 28018 | 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 |
| 78768 | 1794845285 | K921183 | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT | DBM | 1992-06-19 |
| 28018 | 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 |
| 78768 | 1524004920 | K905386 | DISTAT ANTI-DSDNA KIT | KTL | 1990-12-13 |
| 28018 | 1524004920 | K905386 | DISTAT ANTI-DSDNA KIT | KTL | 1990-12-13 |
| 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 |
| 39663 | 1792668032 | K880031 | PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS | LJP | 1988-03-17 |
| 78768 | 1926921197 | K873372 | HVA & HOMOVANILLIC ACID BY HPLC METHOD | CDF | 1987-12-22 |
| 78768 | 1159514108 | K873371 | URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) | CHQ | 1988-01-05 |
| 39663 | 1475634419 | K864663 | PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM | LJP | 1987-02-02 |
| 39663 | 1967041748 | K863682 | PATHFINDER(TM) SPECIMEN COLLECTION KIT | JSM | 1986-10-10 |
| 78768 | 1671764620 | K861010 | VMA BY HPLC TEST (VANILMANDELIC ACID) | CDF | 1986-05-01 |
| 203386 | 1671764620 | K861010 | VMA BY HPLC TEST (VANILMANDELIC ACID) | CDF | 1986-05-01 |
| 39663 | 1239979329 | K852237 | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT | LHL | 1985-08-22 |
| 78768 | 1351114606 | K852237 | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT | LHL | 1985-08-22 |
| 39663 | 1687180668 | K852125 | PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP | GQL | 1985-07-30 |
| 78768 | 1325067446 | K813592 | QUANTAFLUOR FLUORESCENT TEST REAGENTS | DHN | 1982-01-18 |
| 39663 | 1382240287 | K813592 | QUANTAFLUOR FLUORESCENT TEST REAGENTS | DHN | 1982-01-18 |
| 39663 | 1286713466 | K810863 | KALLESTAD HEP-2 CELL LINE SUBSTRATE | DBM | 1981-04-14 |
| 78768 | 1347145541 | K810863 | KALLESTAD HEP-2 CELL LINE SUBSTRATE | DBM | 1981-04-14 |
| 39663 | 1200540915 | K792610 | KALLESTAD FLORESCENT ANA/AMA/ASMA TEST | DBL | 1980-02-22 |
| 39663 | 1003053218 | K780899 | FLUORESCENT ANTI-NATIVE DNA TEST | DHN | 1978-09-07 |
| 78768 | 1603577370 | K780899 | FLUORESCENT ANTI-NATIVE DNA TEST | DHN | 1978-09-07 |
| 28018 | 1623656128 | K183446 | BioPlex 2200 Lyme Total | LSR | 2019-03-12 |
| 78768 | 1623656128 | K183446 | BioPlex 2200 Lyme Total | LSR | 2019-03-12 |
| 230656 | 1069292765 | K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | OYX | 2019-02-13 |
| 78768 | 2011834344 | K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | OYX | 2019-02-13 |
| 28018 | 1003640717 | K180577 | BioPlex 2200 25-OH Vitamin D Kit | MRG | 2018-06-22 |
| 78768 | 1003640717 | K180577 | BioPlex 2200 25-OH Vitamin D Kit | MRG | 2018-06-22 |
| 78768 | 1980146540 | K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | GKA | 2017-09-13 |
| 28018 | 1782938002 | K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set | PUQ | 2017-05-19 |
| 78768 | 1782938002 | K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set | PUQ | 2017-05-19 |
| 28018 | 1114391176 | K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set | LIP | 2017-05-11 |
| 78768 | 1114391176 | K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set | LIP | 2017-05-11 |
| 78768 | 1311320438 | K161687 | D-10 Hemoglobin A1c Program | PDJ | 2016-10-14 |
| 78768 | 1851361432 | K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | PDJ | 2015-12-09 |
| 78768 | 2066010076 | K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | PDJ | 2015-03-24 |
| 203386 | 2066010076 | K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | PDJ | 2015-03-24 |
| 28018 | 1111862513 | K141114 | BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D | MRG | 2015-01-09 |
| 78768 | 1111862513 | K141114 | BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D | MRG | 2015-01-09 |
| 78768 | 1144121754 | K140801 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM | LCP | 2014-06-25 |
| 203386 | 1144121754 | K140801 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM | LCP | 2014-06-25 |
| 28018 | 1758200114 | K132082 | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK | MST | 2013-12-05 |
| 78768 | 1758200114 | K132082 | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK | MST | 2013-12-05 |
| 78768 | 1996423847 | K130990 | VARIANT(TM) II TURBO HBA1C KIT - 2.0 | LCP | 2013-05-09 |
| 203386 | 1996423847 | K130990 | VARIANT(TM) II TURBO HBA1C KIT - 2.0 | LCP | 2013-05-09 |
| 78768 | 1262186332 | K130860 | VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE | LCP | 2013-04-25 |
| 28018 | 1389288322 | K130528 | BIOPLEX 2200 APLS IGM | MID | 2013-10-21 |
| 78768 | 1389288322 | K130528 | BIOPLEX 2200 APLS IGM | MID | 2013-10-21 |
| 28018 | 1949971267 | K130053 | BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI | MVM | 2013-09-19 |
| 78768 | 1949971267 | K130053 | BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI | MVM | 2013-09-19 |
| 28018 | 1158679439 | K123021 | BIOPLEX 2200 EBV IGM KIT | LJN | 2012-11-02 |
| 78768 | 1158679439 | K123021 | BIOPLEX 2200 EBV IGM KIT | LJN | 2012-11-02 |
| 78768 | 2071313135 | K122472 | VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM | LCP | 2012-10-26 |
| 39663 | 1152578435 | K120959 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT | MXJ | 2012-06-22 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LCP | 23 | 2014-06-25 |
| LKJ | 13 | 2012-07-09 |
| LLL | 12 | 2000-04-05 |
| LSE | 10 | 2006-12-08 |
| DHN | 9 | 2003-01-15 |
| NHX | 7 | 2011-10-26 |
| MXJ | 6 | 2012-06-22 |
| LFX | 6 | 2010-12-03 |
| MOB | 6 | 2010-06-03 |
| 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 |
| 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 |
| LKP | 4 | 2003-01-15 |
| JZO | 4 | 2002-05-02 |
| LFZ | 4 | 1999-01-13 |
| DBM | 4 | 1992-06-19 |
| DJG | 3 | 2006-04-21 |
| NVI | 3 | 2005-10-27 |
| LKO | 3 | 1994-04-20 |
| CHQ | 3 | 1989-10-25 |
| CDF | 3 | 1987-12-22 |
| LHL | 3 | 1985-08-22 |
| OYX | 2 | 2019-02-13 |
| PUQ | 2 | 2017-05-19 |
| MVJ | 2 | 2007-10-31 |
| LOM | 2 | 2007-05-31 |
| DKZ | 2 | 2006-11-13 |
| NBT | 2 | 2005-11-14 |
| LAF | 2 | 2002-10-28 |
Bio-Rad Laboratories, Inc.
Bio-Rad Laboratories, Inc.
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