bio-rad.comBlood Establishment Computer Software And Accessories
Bio-Rad Medical Diagnostics GmbH
BIO-RAD MEDICAL DIAGNOSTICS GMBH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9610824 | 3002806595 | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 1 | N | 2026-01-01 | Industrie Str. 1 DREIEICH Hesse DE 63303 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07611969205493 | IH-1000 - Fully automated system for immunohematology diagnostics | 800-224-6723 | techsupport.bmd@bio-rad.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission |
|---|---|---|
| 117537 | 1562896558 | BK980044 |
| 117537 | 1601104870 | BK980033 |
| 117537 | 1261370413 | BK230971 |
| 117537 | 1725329819 | BK220769 |
| 117537 | 1813340203 | BK210625 |
| 117537 | 1321522815 | BK200548 |
| 117537 | 1590781096 | BK190424 |
| 117537 | 1203653883 | BK190388 |
| 117537 | 1166305595 | BK190312 |
| 117537 | 2049970788 | BK180275 |
| 117537 | 1105669393 | BK180274 |
| 117537 | 1475662256 | BK180226 |
| 117537 | 1827261447 | BK180225 |
| 117537 | 1690419626 | BK180175 |
| 117537 | 1875816096 | BK180174 |
| 117537 | 1008514123 | BK170075 |
| 117537 | 1121721664 | BK170071 |
| 117537 | 1480864019 | BK170066 |
| 117537 | 1153121207 | BK170065 |
| 117537 | 1721239198 | BK170064 |
| 117537 | 1837483115 | BK170021 |
| 117537 | 1848898068 | BK170019 |
| 117537 | 1128754185 | BK150327 |
| 117537 | 1686103642 | BK140139 |
| 117537 | 1999000101 | BK140138 |
| 117537 | 1020983006 | BK140107 |
| 117537 | 1957261440 | BK140106 |
| 117537 | 1918433746 | BK130070 |
| 117537 | 1751312198 | BK080013 |
| 117537 | 2004378389 | BK080012 |
| 117537 | 1447960619 | BK040070 |
| 117537 | 1084662585 | BK020004 |
| 117537 | 1169348666 | |
| 117537 | 1262360013 | |
| 117537 | 1398329620 | |
| 117537 | 1798227724 | |
| 117537 | 1853000986 | |
| 117537 | 1860204275 | |
| 117537 | 2013975442 | |
| 117537 | 2058150148 |
PMN#
System, Test, Automated Blood Grouping And Antibody
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Quality Control Kits For Blood Banking Reagents
Bio-Rad Medical Diagnostics GmbH
Quality Control Kits For Blood Banking Reagents
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
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
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Quality Control Kits For Blood Banking Reagents
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Automated Blood Grouping And Antibody Test Systems
Bio-Rad Medical Diagnostics GmbH
Potentiating Media For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
GUDID#
IH-500 - IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens
2019-07-05
IH-1000 - Fully automated system for immunohematology diagnostics
2017-01-20
Lymphoflot - Density gradient for isolation of lymphocytes
2015-07-06
Lymphostabil - For conservation of lymphocytes, free of Ca and Mg, not for infusion
2015-07-06
Hanks Solution - For washing of lymphocytes in the microlymphocytotoxicity test, free of Ca and Mg, not for infusion
2015-07-06
Control-HLA (pos.) - For use in the microlymphocytotoxicity test
2015-07-01
Control-HLA (neg.) - Control-HLA (neg.) (lyo.) 0,5 mlFor use in the microlymphocytotoxicity test
2015-07-01
Control-HLA-DR (pos.) - Control-HLA-DR (pos.) (lyo.) 0,5 mlFor use in the microlymphocytotoxicity test
2015-07-01
HLA-A SSP Kit - for 24 determinations of HLA-A alleles; For In Vitro Diagnostic Use
2015-07-01
HLA-B SSP Kit - for 24 determinations of HLA-B alleles; For In Vitro Diagnostic Use
2015-07-01
HLA-C SSP Kit - Kit for 24 determinations of HLA-C alleles; For In Vitro Diagnostic Use
2015-07-01
DRB SSP Kit - Kit for 24 determinations of HLA-DRB alleles; For In Vitro Diagnostic Use
2015-07-01
DQB SSP Kit - Kit for 24 determinations of HLA-DQB alleles; For In Vitro Diagnostic Use
2015-07-01
ABDR SSPtray - for 24 determinations of HLA-ABDR alleles; For In Vitro Diagnostic Use
2015-07-01
ABC SSPtray - for 24 determinations of HLA-ABC alleles; For In Vitro Diagnostic Use
2015-07-01
Lymphoscreen ABC-60 - Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependend microlymphocytotoxicity test
2018-03-08
Lymphoscreen DR 30x2 - Human lymphocytes for 12 detections of human HLA-DR/DQ antibodies in the complement-dependent microlymphocytotoxicity test
2018-03-08
Wash Solution A Concentrate - Wash Solution for use with the IH-500
2020-02-05
Washing Solution Concentrate - Washing solution for Solidscreen II assays for use with TANGO instruments
2016-03-20
IH-AbID - IH-AbID Integrated Antibody Identification Software is an optional software module for IHCom that provides the user with guidance and information on the identification of antibodies to red blood cell antigens subsequent to the immunohematology testing with the IH-system. The IH-AbID module graphically displays the ruling out of antibodies to red blood cell antigens by reproducing the same logic techniques of antibody identification used in blood transfusion laboratories. For use by trained laboratory personnel, in a (blood transfusion) laboratory environment.
2022-12-13
Alsevers Solution - Suspension medium and stabilizer for red blood cells for TANGO instruments and other immunohaematology methods
2015-07-01
Alsevers Solution - Suspension medium and stabilizer for red blood cells for TANGO instruments and other immunohaematology methods
2016-12-26
TANGO optimo - Instrument
2016-08-15
TANGO infinity - For use with immunohaematology assays
2016-08-15
IH-Centrifuge L - IH-Centrifuge L for centrifugation of IH-System gel cards and/or test tubes.
2018-04-05
IH-Com - IH-Com Kit Fullversion US; Software Version: 04.0.27.
2017-01-20
IH-Com V5.2 - IH-Com V5.2, Software Version 5.2
2021-02-18
IH-Com V5.0 - IH-Com V5.0, Software Version 5.0.10
2017-11-09
IH-Card ABO Neutral - The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells.
2022-03-09
IH-Titration Rack - IH-Titration Rack is a rack with empty wells for plasma/serum dilution used with the IH-500.
2022-03-09
IH-Reader 24 - A combination centrifuge and reader for IH gel cards
2019-01-10
IH-Incubator L - 009303
2018-04-05
IH-Basic QC - Set of 2 x 8 x5 mL pooled whole blood (15.0 ± 2.0%) for quality control testing for use with the IH-System
2018-02-28
IH-Internal QC - For manual Quality Control testing, Set of 5x4 mL red cells in suspension (4 +/- 1%) and 3x3 mL sera (human, polyclonal)
2018-04-05
IH-Titration Solution - IH-Titration Solution is a dilution medium for the titer determination of antibodies in patient and donor samples for use with appropriate IH-Cards.
2022-03-03
Erytype® S ABD+Rev. A1,B - Microplate for ABO and D grouping with the TANGO instruments, 10 Plates
2014-09-17
Erytype® S ABO Donor - Microplate for the detection of the A and B antigens on human red blood cells with TANGO instruments, 10 plates
2014-09-17
IH-Card ABO/D(DVI-)+Rev A1,B - Gel card for use with IH-system; Card for ABO/D(DVI-)+ reverse group A1,B typing; 48 cards of 6 microtubes
2017-01-20
IH-Card ABO/D(DVI+)+Rev A1,B - Blood Grouping Reagent; Gel card for use with IH-system; Card for ABO/D(DVI+)+ reverse group A1,B typing; 48 cards of 6 microtubes
2017-01-20
IH-Card ABD(DVI-)-Conf - Blood Grouping Reagent; Gel card for use with the IH-system; Card for ABD(DVI-) typing; 48 cards of 6 microtubes
2017-01-20