Bio-Rad Laboratories, Inc.

Matched from indexed company URL: BIO-RAD LABORATORIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29152742915274Bio-Rad Laboratories, Inc.1Y2026-01-014000 Alfred Nobel Drive Hercules CA US 94547
30327053002701146BIO-RAD LABORATORIES, INC.1N2026-01-0114620 NE North Woodinville Way Woodinville WA US 98072
30037563383003756338Bio-Rad Laboratories, Inc.1Y2026-01-012500 Atlas Rd Richmond CA US 94804
30078862703008272466BIO-RAD LABORATORIES, INC.1Y2026-01-018415 216th St Se Woodinville WA US 98072
29508801000135116BIO-RAD LABORATORIES, INC.1N2020-04-255500 E 2nd St BENICIA CA US 94510
30225213022521BIO-RAD LABORATORIES, INC.1N2020-04-256565 185th Ave NE Redmond WA US 98052
30105811873010581187BIO-RAD LABORATORIES, INC.1N2020-04-255731 W Las Positas Blvd Pleasanton CA US 94588
30118263603011826360Bio-Rad Laboratories, Inc.1N2020-04-25800 Alfred Nobel Drive Hercules CA US 94547

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
00847661000778Lyphochek - Lyphochek Coagulation Control Level 1 (A human plasma coagulation control.)+1(800)854-6737qsd.techservice@bio-rad.com
00847661000785Lyphochek - Lyphochek Coagulation Control Level 2 (A human plasma coagulation control.)+1(800)854-6737qsd.techservice@bio-rad.com
00847661000792Lyphochek - Lyphochek Coagulation Control Level 3 (A human plasma coagulation control.)+1(800)854-6737qsd.techservice@bio-rad.com
00847661001027Lyphochek - Lyphochek Hemostasis Control Level 1 (A human plasma hemostasis control.)+1(800)854-6737qsd.techservice@bio-rad.com
03610522040131QXDx - QXDx Automated Droplet Generator+1(800)224-6723diagcs@bio-rad.com
03610522040148QXDx - QXDx Droplet Reader+1(800)224-6723diagcs@bio-rad.com
03610522991303QX600 - QX600Dx+1(800)224-6723diagcs@bio-rad.com
03610523006433QXDx - QXDx AutoDG Supermix Pack B+1(800)224-6723diagcs@bio-rad.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
396621042014522P060034BIO RAD MONOLISA ANTI-HBC IGM EIASEI2007-05-31
396631042014522P060034BIO RAD MONOLISA ANTI-HBC IGM EIASEI2007-05-31
396621452972313P060031BIO-RAD MONOLISA ANTI-HBC EIASEI2007-04-27
396631452972313P060031BIO-RAD MONOLISA ANTI-HBC EIASEI2007-04-27
396622015886915P050048MONOLISA ANTI-HBS EIASEI2006-08-25
396632015886915P050048MONOLISA ANTI-HBS EIASEI2006-08-25
396621387723278K991975SERAQUEST EB NA IGGLSE1999-11-02
396631387723278K991975SERAQUEST EB NA IGGLSE1999-11-02
787681137125225K991127VARIANT II B-THALASSEMIAJPD1999-06-10
2033861137125225K991127VARIANT II B-THALASSEMIAJPD1999-06-10
787681404789415K982898IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEMMOB1998-11-30
280181404789415K982898IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEMMOB1998-11-30
396621433515481K982485SERAQUEST CMV IGMLFZ1999-01-13
396631433515481K982485SERAQUEST CMV IGMLFZ1999-01-13
396622015902718K982281SERAQUEST RUBELLA IGMLFX1998-10-16
396632015902718K982281SERAQUEST RUBELLA IGMLFX1998-10-16
396621703448189K980059SERAQUEST MUMPS IGGLJY1998-04-23
396631703448189K980059SERAQUEST MUMPS IGGLJY1998-04-23
396621825327522K972295SERAQUEST VZV IGGLFY1997-11-05
396631825327522K972295SERAQUEST VZV IGGLFY1997-11-05
396621428681968K963282SERAQUEST HSV IGGLGC1997-01-22
396631428681968K963282SERAQUEST HSV IGGLGC1997-01-22
396621126875573K961053SERAQUEST RUBELLA IGGLFX1996-09-04
396631126875573K961053SERAQUEST RUBELLA IGGLFX1996-09-04
396622045175856K960092SERAQUEST TOXOPLASMA IGGLGD1996-06-17
396632045175856K960092SERAQUEST TOXOPLASMA IGGLGD1996-06-17
787681499580392K960091ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KITLRM1996-03-20
280181499580392K960091ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KITLRM1996-03-20
2033861499580392K960091ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KITLRM1996-03-20
787681913699272K954723ENZYME IMMUNOASSAY ANA SCREENING TEST KITLKJ1995-12-15
280181913699272K954723ENZYME IMMUNOASSAY ANA SCREENING TEST KITLKJ1995-12-15
2033861913699272K954723ENZYME IMMUNOASSAY ANA SCREENING TEST KITLKJ1995-12-15
396621759906161K954191SERAQUEST CMV IGGLFZ1996-02-23
396631759906161K954191SERAQUEST CMV IGGLFZ1996-02-23
787681813563809K952817BIO-RAD URINARY 5-HIAA BY HPLCCDA1995-08-01
787681722487835K952253ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KITLLL1995-08-24
280181722487835K952253ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KITLLL1995-08-24
2033861722487835K952253ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KITLLL1995-08-24
787681837375528K952183DIASTAT ANTI-THYROGLOBULIN KITJZO1995-06-30
280181837375528K952183DIASTAT ANTI-THYROGLOBULIN KITJZO1995-06-30
787681279150512K951850ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KITLJM1995-07-18
280181279150512K951850ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KITLJM1995-07-18
2033861279150512K951850ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KITLJM1995-07-18
787681576581655K951798ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KITLJM1995-07-17
280181576581655K951798ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KITLJM1995-07-17
2033861576581655K951798ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KITLJM1995-07-17
787681580856511K942451BIO-RAD CLINICAL DATA MANAGEMENT SYSTEMLDM1994-11-10
787681545733741K940588ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KITLKO1994-04-20
280181545733741K940588ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KITLKO1994-04-20
2033861545733741K940588ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KITLKO1994-04-20
787682038424964K940510ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KITLKP1994-04-20
280182038424964K940510ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KITLKP1994-04-20
2033862038424964K940510ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KITLKP1994-04-20
787681233568873K932419ANTI-SS-B/LA ANTIBODY TESTLLL1993-08-05
280181233568873K932419ANTI-SS-B/LA ANTIBODY TESTLLL1993-08-05
2033861233568873K932419ANTI-SS-B/LA ANTIBODY TESTLLL1993-08-05
787681801905803K931495ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KITLLL1993-07-16
280181801905803K931495ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KITLLL1993-07-16
2033861801905803K931495ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KITLLL1993-07-16
787681794845285K921183DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KITDBM1992-06-19
280181794845285K921183DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KITDBM1992-06-19
396622032114725K911590IMMUNOWELL BORRELIA (LYME)TESTLSR1991-12-20
396632032114725K911590IMMUNOWELL BORRELIA (LYME)TESTLSR1991-12-20
787681524004920K905386DISTAT ANTI-DSDNA KITKTL1990-12-13
280181524004920K905386DISTAT ANTI-DSDNA KITKTL1990-12-13
787681905156398K894966PLASMA CATECHOLAMINES BY HPLCCHQ1989-10-25
2033861905156398K894966PLASMA CATECHOLAMINES BY HPLCCHQ1989-10-25
787681014252576K890768PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KITLYF1989-03-21
396631686277221K890768PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KITLYF1989-03-21
396631792668032K880031PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATISLJP1988-03-17
787681926921197K873372HVA & HOMOVANILLIC ACID BY HPLC METHODCDF1987-12-22
787681159514108K873371URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)CHQ1988-01-05
396631475634419K864663PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEMLJP1987-02-02
396631967041748K863682PATHFINDER(TM) SPECIMEN COLLECTION KITJSM1986-10-10
787681671764620K861010VMA BY HPLC TEST (VANILMANDELIC ACID)CDF1986-05-01
2033861671764620K861010VMA BY HPLC TEST (VANILMANDELIC ACID)CDF1986-05-01
396631239979329K852237LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KITLHL1985-08-22
787681351114606K852237LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KITLHL1985-08-22
396631687180668K852125PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMPGQL1985-07-30
787681325067446K813592QUANTAFLUOR FLUORESCENT TEST REAGENTSDHN1982-01-18
396631382240287K813592QUANTAFLUOR FLUORESCENT TEST REAGENTSDHN1982-01-18
396631286713466K810863KALLESTAD HEP-2 CELL LINE SUBSTRATEDBM1981-04-14
787681347145541K810863KALLESTAD HEP-2 CELL LINE SUBSTRATEDBM1981-04-14
396631200540915K792610KALLESTAD FLORESCENT ANA/AMA/ASMA TESTDBL1980-02-22
396631003053218K780899FLUORESCENT ANTI-NATIVE DNA TESTDHN1978-09-07
787681603577370K780899FLUORESCENT ANTI-NATIVE DNA TESTDHN1978-09-07
280181623656128K183446BioPlex 2200 Lyme TotalLSR2019-03-12
787681623656128K183446BioPlex 2200 Lyme TotalLSR2019-03-12
2306561069292765K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemOYX2019-02-13
787682011834344K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemOYX2019-02-13
280181003640717K180577BioPlex 2200 25-OH Vitamin D KitMRG2018-06-22
787681003640717K180577BioPlex 2200 25-OH Vitamin D KitMRG2018-06-22
787681980146540K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareGKA2017-09-13
280181782938002K170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control SetPUQ2017-05-19
787681782938002K170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control SetPUQ2017-05-19
280181114391176K170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetLIP2017-05-11
787681114391176K170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetLIP2017-05-11
787681311320438K161687D-10 Hemoglobin A1c ProgramPDJ2016-10-14
787681851361432K151321D-100 HbA1c, D-100 HbA1c Calibrator PackPDJ2015-12-09
787682066010076K142448VARIANT II TURBO HbA1c Kit - 2.0PDJ2015-03-24
2033862066010076K142448VARIANT II TURBO HbA1c Kit - 2.0PDJ2015-03-24
280181111862513K141114BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN DMRG2015-01-09
787681111862513K141114BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN DMRG2015-01-09
787681144121754K140801VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEMLCP2014-06-25
2033861144121754K140801VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEMLCP2014-06-25
280181758200114K132082AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECKMST2013-12-05
787681758200114K132082AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECKMST2013-12-05
787681996423847K130990VARIANT(TM) II TURBO HBA1C KIT - 2.0LCP2013-05-09
2033861996423847K130990VARIANT(TM) II TURBO HBA1C KIT - 2.0LCP2013-05-09
787681262186332K130860VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARELCP2013-04-25
280181389288322K130528BIOPLEX 2200 APLS IGMMID2013-10-21
787681389288322K130528BIOPLEX 2200 APLS IGMMID2013-10-21
280181949971267K130053BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BIMVM2013-09-19
787681949971267K130053BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BIMVM2013-09-19
280181158679439K123021BIOPLEX 2200 EBV IGM KITLJN2012-11-02
787681158679439K123021BIOPLEX 2200 EBV IGM KITLJN2012-11-02
787682071313135K122472VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEMLCP2012-10-26
396631152578435K120959BIOPLEX 2200 HSV-1 AND HSV-2 IGG KITMXJ2012-06-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCP232014-06-25
LKJ132012-07-09
LLL122000-04-05
LSE102006-12-08
DHN92003-01-15
NHX72011-10-26
MXJ62012-06-22
LFX62010-12-03
MOB62010-06-03
LRM62000-09-11
LJM61995-07-18
LIP52017-05-11
OMI52012-03-26
OPL52011-08-23
LSR42019-03-12
MRG42018-06-22
GKA42017-09-13
PDJ42016-10-14
MST42013-12-05
MID42013-10-21
MVM42013-09-19
LJN42012-11-02
LOM 42007-04-27
LKP42003-01-15
JZO42002-05-02
LFZ41999-01-13
DBM41992-06-19
DJG32006-04-21
NVI32005-10-27
LKO31994-04-20
CHQ31989-10-25
CDF31987-12-22
LHL31985-08-22
OYX22019-02-13
PUQ22017-05-19
MVJ22007-10-31
LOM22007-05-31
DKZ22006-11-13
NBT22005-11-14
LAF22002-10-28

PMA#

PMN#

82 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next