Bio Rad Medical Diagnostics G M B H

FDA Filings

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

FDA Registration(s)
Registration Number9610824
FEI Number3002806595
NameDavid Bhend
Owner & OperatorBio-Rad Medical Diagnostics GmbH
Contact AddressIndustriestrasse 1
Dreieich DE-HE Hessen 63303 DE
Official Correspondent
  • Marc Gorzellik, PH.D.
  • 49-6103-3130-528
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6565 185th Ave NE
Redmond, WA 98052 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Export Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
Bio-Rad Medical Diagnostics GmbH
Blood Establishment Computer Software And Accessories2022-12-07
Bio-Rad Medical Diagnostics GmbH
IH-Com 0091002022-03-22
Bio-Rad Medical Diagnostics GmbH
IH-Titration Rack 8135501002022-03-17
Bio-Rad Medical Diagnostics GmbH
IH-Card ABO Neutral 120087222022-03-17
Bio-Rad Medical Diagnostics GmbH
IH-Titration Solution 8135601002022-03-11
Bio-Rad Medical Diagnostics GmbH
IH-500 0015102022-01-31
Bio-Rad Medical Diagnostics GmbH
IH-Com V5.2 120102362021-02-26
Bio-Rad Medical Diagnostics GmbH
System, Test, Automated Blood Grouping And Antibody2021-01-13
Bio-Rad Medical Diagnostics GmbH
Wash Solution A Concentrate 2020-02-13
David Bhend [Bio-Rad Medical Diagnostics GmbH]
TANGO infinity2020-01-29
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Wash Solution A Concentrate2020-01-24
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2019-12-20
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2019-12-13
Bio-Rad Medical Diagnostics GmbH
Alsevers Solution 8065101002019-11-27
Bio-Rad Medical Diagnostics GmbH
Alsevers Solution 8065101002019-11-27
David Bhend [Bio-Rad Medical Diagnostics GmbH]
TANGO infinity2019-06-21
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Com2019-05-27
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-5002019-05-14
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2019-04-25
Bio-Rad Medical Diagnostics GmbH
Solidscreen II-Control B 8065191002019-03-22
Bio-Rad Medical Diagnostics GmbH
Solidscreen II Negative Control 8065091002019-03-22
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2019-03-21
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2019-03-21
Bio-Rad Medical Diagnostics GmbH
Seraclone Anti-k (KEL2) 8081261002019-02-15
Bio-Rad Medical Diagnostics GmbH
IH-Reader 24 0012002019-02-11
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Com V5.02018-11-16
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Reader 242018-11-16
Bio-Rad Medical Diagnostics GmbH
IH-Com V5.0 0091012018-10-24
Bio-Rad Medical Diagnostics GmbH
IH-1000 0011002018-10-24
David Bhend [Bio-Rad Medical Diagnostics GmbH]
TANGO infinity2018-10-23
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Com V5.02018-10-23
Bio-Rad Medical Diagnostics GmbH
TANGO infinity 8500000102018-10-16
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2018-09-28
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2018-09-28
Bio-Rad Medical Diagnostics GmbH
MLB 2 8052051002018-09-12
Bio-Rad Medical Diagnostics GmbH
MLB 2 8052001002018-09-12
Bio-Rad Medical Diagnostics GmbH
IH-LISS Solution 2018-09-12
Bio-Rad Medical Diagnostics GmbH
MLB 2 8052051002018-09-12
Bio-Rad Medical Diagnostics GmbH
MLB 2 8052001002018-09-12
Bio-Rad Medical Diagnostics GmbH
IH-LISS Rack 8135101002018-09-12
Bio-Rad Medical Diagnostics GmbH
Bromelin for Erytype 8062101002018-07-06
Bio-Rad Medical Diagnostics GmbH
Lymphoscreen DR 30x2 2018-07-06
Bio-Rad Medical Diagnostics GmbH
Lymphoscreen ABC-60 2018-07-06
Bio-Rad Medical Diagnostics GmbH
IH-Card Neutral 8136121002018-07-06
Bio-Rad Medical Diagnostics GmbH
IH-Card Neutral 8136101002018-07-06
Bio-Rad Medical Diagnostics GmbH
TANGO optimo 8489000102018-07-06
Bio-Rad Medical Diagnostics GmbH
ABC SSPtray 8262402018-07-06
Bio-Rad Medical Diagnostics GmbH
ABDR SSPtray 8262302018-07-06
Bio-Rad Medical Diagnostics GmbH
DQB SSP Kit 8262202018-07-06
Bio-Rad Medical Diagnostics GmbH
Control-HLA-DR (pos.) 8241102018-07-06
Bio-Rad Medical Diagnostics GmbH
Control-HLA (neg.) 8241062018-07-06
Bio-Rad Medical Diagnostics GmbH
Control-HLA (pos.) 8241012018-07-06
Bio-Rad Medical Diagnostics GmbH
Lymphoscreen ABC-60 8233002018-07-06
Bio-Rad Medical Diagnostics GmbH
Coombscell-E 8160301002018-07-06
Bio-Rad Medical Diagnostics GmbH
IH-Internal QC 2018-07-06
Bio-Rad Medical Diagnostics GmbH
IH-Basic QC 2018-07-06
Bio-Rad Medical Diagnostics GmbH
IH-Card Neutral 8136111002018-07-06
Bio-Rad Medical Diagnostics GmbH
IH-Card Control 8136001002018-07-06
Bio-Rad Medical Diagnostics GmbH
Solidscreen II Strip 8065211002018-07-06
Bio-Rad Medical Diagnostics GmbH
Solidscreen II-Control 8065141002018-07-06
Bio-Rad Medical Diagnostics GmbH
Bromelin for Erytype 8062101002018-07-06
Bio-Rad Medical Diagnostics GmbH
Seraclone Control AB0+Rh 8051711002018-07-06
Bio-Rad Medical Diagnostics GmbH
IH-Incubator L 2018-07-06
Bio-Rad Medical Diagnostics GmbH
IH-Centrifuge L 2018-07-06
Bio-Rad Medical Diagnostics GmbH
Lymphoflot 8240122018-06-11
Bio-Rad Medical Diagnostics GmbH
IH-Papain 2018-05-07
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2018-05-01
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2018-05-01
Bio-Rad Medical Diagnostics GmbH
Biotestcell® A1 & B 8160571002018-03-29
Bio-Rad Medical Diagnostics GmbH
Erytypecell® A1 & B 8160561002018-03-29
Bio-Rad Medical Diagnostics GmbH
Biotestcell® A2 8160471002018-03-29
Bio-Rad Medical Diagnostics GmbH
Biotestcell®-I 11 Plus 8160221002018-03-29
Bio-Rad Medical Diagnostics GmbH
Biotestcell®-I 11 8160211002018-03-29
Bio-Rad Medical Diagnostics GmbH
Biotestcell®-I 8 8160201002018-03-29
Bio-Rad Medical Diagnostics GmbH
Biotestcell® 1 & 2 8160141002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Panel Plus 6 8140901002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Panel 11 Papain 8140801002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Panel 11 8140701002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Cell Pool 8140601002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Cell I-II 8140501002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Cell I-II-III 8140301002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Cell A2 8140201002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Cell A1 & B 8140101002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Anti D (RH1) Blend 8138041002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Card AHG Anti-IgG 8134211002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Card AHG Anti-IgG,-C3d 8134111002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Card Rh-Phenotype+K 8132011002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Card ABD(DVI+)-Conf 8131911002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Card ABD(DVI-)-Conf 8131811002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Card Group A,B 8131411002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Card ABO/D(DVI+)+Rev A1,B 8131211002018-03-29
Bio-Rad Medical Diagnostics GmbH
IH-Card ABO/D(DVI-)+Rev A1,B 8131111002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-N (MNS2) 8084151002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-M (MNS1) 8084101002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-Lea (LE1) 8084031002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-Fya (JK1) 8081881002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-Jkb (JK2) 8081841002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-Jka (JK1) 8081791002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-P1 (P1) 8081581002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-k (KEL2) 8081251002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-K (KEL1) 8080901002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-s (MNS4) 8080681002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-S (MNS3) 8080521002018-03-29
Bio-Rad Medical Diagnostics GmbH
Solidscreen II Anti-D (RH1) Blend 8065301002018-03-29
Bio-Rad Medical Diagnostics GmbH
Anti-Human Globulin Anti-IgG Solidscreen II 8065161002018-03-29
Bio-Rad Medical Diagnostics GmbH
Erytype S Rh+K Type 8061951002018-03-29
Bio-Rad Medical Diagnostics GmbH
Erytype® S Rh Donor 8061901002018-03-29
Bio-Rad Medical Diagnostics GmbH
Erytype® S ABO Donor 8061301002018-03-29
Bio-Rad Medical Diagnostics GmbH
Erytype® S ABD+Rev. A1,B 8061271002018-03-29
Bio-Rad Medical Diagnostics GmbH
Anti-Human-Globulin, Anti-IgG 8041751002018-03-29
Bio-Rad Medical Diagnostics GmbH
Anti-Human-Globulin, Anti-IgG, -C3d; polyspecific 8041151002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-e (RH5) 8023701002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-c (RH4) 8023461002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-E (RH3) 8023361002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-C (RH2) 8022801002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-D (RH1) 8020421002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-D (RH1) Blend 8020331002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-A,B (ABO3) 8013751002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-B (ABO2) 8013501002018-03-29
Bio-Rad Medical Diagnostics GmbH
Seraclone® Anti-A (ABO1) 8013251002018-03-29
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Basic QC2018-01-03
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Incubator L2018-01-03
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Centrifuge L2018-01-03
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Internal QC2018-01-03
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Papain2018-01-03
Bio-Rad Medical Diagnostics GmbH
Quality Control Kits For Blood Banking Reagents2017-12-20
Bio-Rad Medical Diagnostics GmbH
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2017-12-18
Bio-Rad Medical Diagnostics GmbH
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2017-12-18
Bio-Rad Medical Diagnostics GmbH
Quality Control Kits For Blood Banking Reagents2017-12-18
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Com V5.02017-10-16
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Com V5.02017-10-16
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-10002017-10-16
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2017-09-26
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2017-05-05
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2017-05-05
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Centrifuge L2017-05-05
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Incubator L2017-05-05
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Card Control2016-11-21
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Card Neutral2016-11-21
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Com2016-11-21
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-10002016-11-21
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Liss Solution2016-11-21
David Bhend [Bio-Rad Medical Diagnostics GmbH]
IH-Liss Rack2016-11-21
Bio-Rad Medical Diagnostics GmbH
Quality Control Kits For Blood Banking Reagents2016-10-20
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2016-10-20
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2016-10-20
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2016-10-20
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Washing Solution Concentrate2016-01-12
David Bhend [Bio-Rad Medical Diagnostics GmbH]
TANGO infinity2016-01-12
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems2015-12-16
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Quickstep2015-04-07
David Bhend [Bio-Rad Medical Diagnostics GmbH]
MLB 2 10 x 10 mL2014-01-13
Bio-Rad Medical Diagnostics GmbH
Potentiating Media For In Vitro Diagnostic Use2013-11-27
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Lymphostabil2013-10-21
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Hanks Solution2013-10-21
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Lymphoflot2013-10-21
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Lymphoscreen DR 30 x 22010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Kontroll-HLA-DR pos.2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Kontroll-HLA neg.2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Lymphoscreen ABC 602010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Kontroll-HLA pos.2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Kontroll-HLA neg.2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
TANGO Optimo SW Version 3.12010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Solidscreen II Negative Control2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Solidscreen II Control B2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Erytype S Rh+K Type2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Alsevers Solution2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Seraclone Control ABO+Rh2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
MLB22010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Coombscell-E2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
TANGO Automated Blood Bank Analyzer2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Solidscreen II2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Solidscreen II Strip2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Solidscreen II Negative Control2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Solidscreen II Control2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Negative Control2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
MLB22010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
MLB 22010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Erytype S Rh Donor2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Erytype S Rh Donor Confirmation2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Erytype S ABO Donor2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Erytype S ABO Donor Confirmation2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Erytype S ABD+Rev. A1,B2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Bromelin2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
Bromelin for Erytype2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
HLA-C SSP Kit2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
HLA-B SSP Kit2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
HLA-A SSP Kit2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
DRB SSP Kit2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
DQB SSP Kit2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
ABDR SSPtray2010-06-01
David Bhend [Bio-Rad Medical Diagnostics GmbH]
ABC SSPtray2010-06-01

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