Bio Rad

FDA Filings

This page includes the latest FDA filings for Bio Rad. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005963273
FEI Number3005963273
NameDavid Bhend
Owner & OperatorBIO-RAD
Contact Address3 BOULEVARD RAYMOND POINCARE --
MARNES-LA-COQUETTE FR-NOTA 92430 FR
Official Correspondent
  • Sylvie - FERNEZ
  • 33-1-4795-6000
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6565 185th Ave NE
Redmond, WA 98052 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

Registration Number9615711
FEI Number3007143271
NameBIO-RAD
Owner & OperatorBIO-RAD
Contact Address3 BOULEVARD RAYMOND POINCARE --
MARNES-LA-COQUETTE FR-NOTA 92430 FR
Official Correspondent
  • Sylvie - FERNEZ
  • 33-1-4795-6000
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7 RUE DE MADRID
SCHILTIGHEIM Bas-Rhin, 67300 FR
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number8023060
FEI Number3003992026
NameBIO-RAD
Owner & OperatorBIO-RAD
Contact Address3 BOULEVARD RAYMOND POINCARE --
MARNES-LA-COQUETTE FR-NOTA 92430 FR
Official Correspondent
  • Sylvie - FERNEZ
  • 33-1-4795-6000
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressROUTE DE CASSEL
STEENVOORDE Nord, 59114 FR
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
BIO-RAD
 PLATELIA 252972023-08-09
BIO-RAD
 PLATELIA 252962023-08-09
BIO-RAD
 Select 637472023-08-09
BIO-RAD
 Platelia 120152532023-07-11
BIO-RAD
 Platelia 120152892023-07-11
BIO-RAD
 BIO-RAD 875302023-02-13
BIO-RAD
 PR 4100 915872023-02-13
BIO-RAD
 EVOLIS 896012023-02-13
BIO-RAD
 GEENIUS 924652023-02-13
BIO-RAD
 Select 637402023-01-13
BIO-RAD
 Select 637482023-01-13
BIO-RAD
Hemoglobin Capillary Collection System2019-08-07
BIO-RAD
Hemoglobin Capillary Collection System2019-08-07
David Bhend [BIO-RAD]
IH-5002019-05-14
David Bhend [BIO-RAD]
IH-Reader 242018-11-29
BIO-RAD
 MONOLISA 724952018-07-06
BIO-RAD
 MONOLISA 724962018-07-06
BIO-RAD
MRSASelect II2018-01-08
David Bhend [BIO-RAD]
IH-Incubator L2018-01-08
David Bhend [BIO-RAD]
IH-Centrifuge L2018-01-08
Bio-Rad
MRSASelect II2017-12-28
David Bhend [BIO-RAD]
IH-COM V5.02017-10-18
David Bhend [BIO-RAD]
IH-COM V5.02017-10-18
David Bhend [BIO-RAD]
IH-10002017-10-18
David Bhend [BIO-RAD]
IH-Centrifuge L2017-05-05
David Bhend [BIO-RAD]
IPS Microplate Incubator2017-05-02
David Bhend [BIO-RAD]
IH-Incubator L2017-05-02
David Bhend [BIO-RAD]
IH-COM2016-11-15
David Bhend [BIO-RAD]
IH-10002016-11-15
BIO-RAD
D-100 Hemoglobin Testing System2016-01-22
BIO-RAD
D-10 Hemoglobin Testing System2016-01-22
BIO-RAD
Geenius HIV 1/2 Supplemental Assays and Controls2014-11-14
BIO-RAD
Geenius Reader & accessories2014-11-14
BIO-RAD
EVOLIS Microplate System2013-01-29
BIO-RAD
ELITE Microplate System2013-01-29
BIO-RAD
Magellan for PR41002013-01-14
BIO-RAD
PR41002013-01-14
BIO-RAD
PR31002013-01-14
BIO-RAD
VRE Select (stool claim)2012-12-05
BIO-RAD
VRESELECT CULTURE MEDIUM2012-11-06
BIO-RAD
Platelia Aspergillus IgG Negative and Positive Controls2012-03-20
BIO-RAD
Platelia Aspergillus IgG2012-03-20
BIO-RAD
VRESelect Culture Medium2011-12-28
BIO-RAD
VRESELECT CULTURE MEDIUM2011-10-21
BIO-RAD
Uriselect 42011-01-25
BIO-RAD
CandiSelect2011-01-25
BIO-RAD
CandiSelect 42011-01-25
BIO-RAD
Platelia Aspergillus Ag2011-01-24
BIO-RAD
PLATELIA ASPERGILLUS EIA MODEL 627932011-01-13
BIO-RAD
SA Select2010-12-22
BIO-RAD
MRSA Select - wound specimens2010-11-26
BIO-RAD
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS2010-10-29
BIO-RAD
MONOLISA anti-HAV EIA on EVOLIS2009-12-01
BIO-RAD
MONOLISA anti-HAV EIA on EVOLIS2009-12-01
BIO-RAD
MONOLISA anti-HAV IgM EIA on EVOLIS2009-12-01
BIO-RAD
MONOLISA anti-HAV IgM EIA on EVOLIS2009-12-01
BIO-RAD
PLATELIA Toxo IgM kit2009-11-24
BIO-RAD
PLATELIA Lyme IgM2008-07-11
BIO-RAD
PLATELIA LYME IGM2008-06-26
BIO-RAD
MRSASELECT - EXTENDED INCUBATION2008-06-13
BIO-RAD
Platelia Lyme IgG2008-05-13
BIO-RAD
PLATELIA LYME IGG ASSAY2008-05-08
BIO-RAD
Anti-HIV Antibody ASR2008-03-14
BIO-RAD
PLATELIA ASPERGILLUS EIA2008-01-08
BIO-RAD
MRSA Select2007-10-26
BIO-RAD
MRSASELECT2007-09-13
BIO-RAD
MONOLISA ANTI-HAV IGM EIA2007-06-06
BIO-RAD
MONOLISA ANTI-HAV EIA2007-06-06
BIO-RAD
PHD lx2007-02-09
BIO-RAD
PHD (FORMERLY DUET)2007-02-09
BIO-RAD
PATHFINDER RSV2006-06-29
BIO-RAD
PATHFINDER ROTAVIRUS2006-06-29
BIO-RAD
ACCESS CEA2006-06-29
BIO-RAD
PASTOREX STAPH-PLUS1998-07-15
BIO-RAD
PW411998-07-15
BIO-RAD
PW401998-07-15
BIO-RAD
ACCESS RUBELLA IGG1996-07-16
Bio-Rad
 BIO-RAD CYCLOSPORINE BY HPLC TEST1996-03-01
Bio-Rad
 BIO-RAD CYCLOSPORINE BY HPLC TEST1991-03-14
BIO-RAD
ACCESS TOXO IGM II1989-08-14
BIO-RAD
ACCESS TOXO IGM II1989-08-14
BIO-RAD
PLATELIA TOXO IGG1989-08-14
BIO-RAD
PLATELIA TOXO IGM1989-08-14
Bio-Rad
 BIO-RAD CYCLOSPORINE BY HPLC TEST1989-07-24

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE CodeFANP8BIO-RAD
NCAGE CodeFA9G5BIO RAD
CAGE CodeFA9G5BIO RAD
CAGE CodeFANP8BIO-RAD EMERGING MARKETS SUBSIDIARY
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020090233125Marseille,France -> Houston, TexasFREIGHT PREPAID CONTAINING BODY WHITE CARD 4FF PICO CARD PICO 2T CARD42 PCS
2020081835531Marseille,France -> Houston, TexasFREIGHT PREPAID BODY WHITE CARD PICO 2T CARD20 PCS
2020081743669Marseille,France -> Houston, TexasFREIGHT PREPAID BODY WHITE CARD PICO 2T CARD20 PCS
2020072830088Marseille,France -> Houston, TexasFREIGHT PREPAID CONTAINING BODY WRITE CARDS: TARJETA SIM 4 FF PICO AND TARJETA PICO 2T 4FF PICO SIM CARD AND PICO 2T CARD42 PCS
2020072743417Marseille,France -> Houston, TexasFREIGHT PREPAID CONTAINING BODY WRITE CARDS: TARJETA SIM 4 FF PICO AND TARJETA PICO 2T 4FF PICO SIM CARD AND PICO 2T CARD42 PCS
2020062226961Marseille,France -> Houston, TexasFREIGHT PREPAID ON 24 PALLBOXES WHITE PLASTIC CARD BODIES HS CODE: 3926.90 CONSIGNEE CONTACT: EMILIO ENCARNACION PADILL TEL: +52 777 3293564 MOB: +52 777 500694240 PCS
2020052528740Marseille,France -> Houston, TexasFREIGHT PREPAID CONSIGNEE CONTACT: EMILIO ENCARNACION PADILLA TEL: +52 777 3293564 MOB: +52 777 5006942 EMILIO.ENCARNACIONPADILLA THALESGROUP.COM WHITE PLASTIC CARD BODIES HS CODE: 3926.9040 PCS
2020050433209Marseille,France -> Houston, TexasFREIGHT PREPAID EMILIO ENCARNACION PADILLA TEL: +52 777 3293564 MOB: +52 777 5006942 EMILIO.ENCARNACIONPADILLA THALESGROUP.COM WHITE PLASTIC CARD BODIES HS CODE: 3926.9024 PCS
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