IMMUCOR, INC.

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• immucor.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• System, Test, Automated Blood Grouping And Antibody

  2021-09-03

  Immucor, Inc.

• System, Test, Automated Blood Grouping And Antibody

  2021-09-03

  Immucor, Inc.

• Capture-CMV

  2021-03-22

  Immucor, Inc.

• 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

  2020-06-22

  Immucor, Inc.

• 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

  2020-06-12

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2019-06-19

  Immucor, Inc.

• Capture-CMV

  2019-02-04

  Immucor, Inc.

• CMV Tests For Donors

  2018-11-20

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2018-11-07

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2018-07-17

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2018-04-27

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2018-04-27

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2017-07-19

  Immucor, Inc.

• 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

  2015-11-19

  Immucor, Inc.

• Test, Syphilis, Treponema (FOR DONOR TESTING)

  2012-10-24

  Immucor, Inc.

• 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

  2012-06-14

  Immucor, Inc.

• Fetal Hemoglobin Assay

  2012-05-22

  Immucor, Inc.

• Quality Control Kits For Blood Banking Reagents

  2011-10-03

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2010-08-23

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2010-07-09

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2010-04-29

  Immucor, Inc.

• Quality Control Kits For Blood Banking Reagents

  2007-09-28

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2007-06-14

  Immucor, Inc.

• Quality Control Kits For Blood Banking Reagents

  2007-06-14

  Immucor, Inc.

• Kit, Quality Control For Blood Banking Reagents

  2006-05-09

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  2004-04-28

  Immucor, Inc.

• 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

  2004-04-23

  Immucor, Inc.

• Quality Control Kits For Blood Banking Reagents

  2004-04-23

  Immucor, Inc.

• Kit, Quality Control For Blood Banking Reagents

  2004-04-22

  Immucor, Inc.

• Kit, Quality Control For Blood Banking Reagents

  2003-01-27

  Immucor, Inc.

• Test, Syphilis, Treponema (FOR DONOR TESTING)

  2000-06-22

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  1998-06-30

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  1998-06-30

  Immucor, Inc.

• Blood Bank Supplies

  1997-10-24

  Immucor, Inc.

• Quality Control Kits For Blood Banking Reagents

  1997-07-21

  Immucor, Inc.

• Quality Control Kits For Blood Banking Reagents

  1997-06-04

  Immucor, Inc.

• Automated Blood Grouping And Antibody Test Systems

  1997-06-04

  Immucor, Inc.

• Test, Donor, CMV

  1995-12-22

  Immucor, Inc.

• Potentiating Media For In Vitro Diagnostic Use

  1993-09-21

  Immucor, Inc.

• CYTOMEGALOVIRUS ANTIBODY SCREEN

  1991-03-20

  IMMUCOR, INC.

59 records. Showing 1-40. Next

GUDID#

• Capture LISS - Capture LISS for Capture-R Ready Screen (10X) is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%). The reagent will turn from blue purple to sky blue or turquoise in the presence of normal human serum or plasma.

  IMMUCOR, INC.

  2022-09-03

• H.P.C. (Human Platelet Concentrate) - H.P.C. (Human Platelet Concentrate) is used to reduce or remove HLA (Bg) activity from serum as an aid in antibody detection and identification. H.P.C. is a dry preparation of a washed pool of platelets from individual human platelet donors. This product is a dry preparation which must be rehydrated before use. This product configuration has ten (10) vials.

  IMMUCOR, INC.

  2016-04-18

• ImmuLINK - ImmuLINK is middleware software that allows the user to link the application software database on automated (and/or semi-automated) blood bank instruments; the user may also link the instrument database(s) with the user’s Laboratory Information System (LIS). ImmuLINK is software designed to provide an interface between the user, blood bank instruments, and Blood Establishment Computer. ImmuLINK allows integration of sample, donor, or patient data that has been collected from multiple sources and provides data management tools to create customizable reports from the diverse data.

  IMMUCOR, INC.

  2024-12-05

• Red Blood Cell (RBC) Storage Solution - Red Blood Cell (RBC) Storage Solution is a general purpose reagent intended for use in suspending and preserving red blood cells that can be subsequently used for in vitro immunohematology testing. Red Blood Cell (RBC) Storage Solution is a buffered preservation solution containing adenosine and adenine to retard hemolysis and/or loss of antigenicity. The product is a one (1) liter bag configuration.

  IMMUCOR, INC.

  2016-04-15

• Specimen Diluent - Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is ten (10) vials of 11.5 mL volume.

  IMMUCOR, INC.

  2016-04-18

• Specimen Diluent - Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is six (6) vials of 57 mL volume.

  IMMUCOR, INC.

  2016-04-18

• Galileo Neo - The Galileo Neo (NEO) is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO automates test processing, result interpretation and data management functions. The NEO is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening and infectious disease screening, such as cytomegalovirus (CMV). The antigen screening assays provide guidelines for the user to select antisera or dilute commercial blood grouping reagents as a mechanism to pre-screen for antigen negative blood units that can then be subjected to confirmation using a licensed method.

  IMMUCOR, INC.

  2016-04-18

• Galileo Echo - The Galileo Echo is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo Echo automates test processing, result interpretation, and data management functions. The Galileo Echo is designed to automate standard immunohematology assays using a microstrip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping.

  IMMUCOR, INC.

  2016-04-18

• CMT Plates - CMT Plates are intended to be used in hemagglutination assays on Immucor automated instruments. CMT Plates are composed of micro-wells coated to block the nonspecific adsorption of red blood cells or serum proteins to the plastic wells. CMT Plates are supplied in a plate format. Each plate has twelve strips on a support frame and each strip has eight micro-wells. Strips can be used individually or in multiples. This product configuration is forty (40) microplates.

  IMMUCOR, INC.

  2016-04-18

• NEO Iris - The NEO Iris is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO Iris automates test processing, result interpretation and data management functions. The NEO Iris is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping and antigen screening. The NEO Iris is for in-vitro diagnostic use.

  IMMUCOR, INC.

  2018-12-10

• Echo Lumena - The Echo Lumena is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Echo Lumena automates test processing, result interpretation, and data management functions. The Echo Lumena is designed to automate standard immunohematology assays using a microstrip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping.

  IMMUCOR, INC.

  2018-06-01

• Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum - Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-R Solid Phase Assays, including Capture-R Select, Capture-R Ready-Screen and Capture-R Ready-ID. Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells and sodium azide added as a preservative. Capture-R Negative Control Serum contains no antibodies to red blood cells; sodium azide is added as a preservative.

  IMMUCOR, INC.

  2022-09-03

• Capture-R Select - The Capture-R Select Solid Phase System provides modified microwells for the immobilization of human erythrocytes for use in solid phase assays for the detection of IgG red blood cell antibodies to corresponding red blood cell antigens (e.g., antibody screening, selected red blood cell panels, crossmatching, or antigen phenotyping).

  IMMUCOR, INC.

  2022-09-03

• Capture-P - Capture-P Solid Phase System is intended for use in the detection of antibodies to platelets. Capture-P Solid Phase System is designed to detect the unexpected antiplatelet antibodies (antibody screening test) in a patient or donor population.

  IMMUCOR, INC.

  2022-09-03

• Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum - Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capture-P and Capture-P Ready-Screen Solid Phase assays.

  IMMUCOR, INC.

  2022-09-03

• Capture-R Ready Indicator Red Cells - Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays for the detection of IgG antibodies to red blood cells.

  IMMUCOR, INC.

  2022-09-03

• Capture-P Indicator Red Cells - Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen solid phase assays for the detection of IgG antibodies to platelets. Capture-P Indicator Red Cells are a suspension of red blood cells coated with rabbit anti-human IgG. The red blood cells are suspended in a buffered preservative solution to which chloramphenicol (0.25 mg/mL) , neomycin sulfate (0.1 mg/mL) and gentamycin sulfate (0.05 mg/mL) have been added as preservatives.

  IMMUCOR, INC.

  2022-09-03

• Referencells - Referencells (Pooled Cells) are intended for use in tube and microplate ABO serum grouping tests.

  IMMUCOR, INC.

  2022-08-03

• Capture-R Ready-Screen 3 - Capture-R Ready-Screen (3) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods.

  IMMUCOR, INC.

  2022-08-01

• Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent - Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is intended for the detection of the Fya (FY1) antigen on red blood cells with the indirect antiglobulin test by tube and microplate technique.Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is prepared from IgG antibodies from the human/murine heterohybridoma cell line P3TIM grown in fluid culture and suitably diluted in a proprietary diluent containing bovine albumin to achieve the appropriate level of potency for the test procedure as described. Sodium azide is added as a preservative (at less than 0.1% w/v). Ready for use as supplied.

  IMMUCOR, INC.

  2022-04-22

• Anti-s (Monoclonal) Gamma-clone - Anti-s (Monoclonal) Gamma-clone reagent is intended for the detection of the s (MNS4) antigen on red blood cells by tube test.

  IMMUCOR, INC.

  2022-04-22

• Anti-S (Monoclonal) Gamma-clone - Anti-S (Monoclonal) Gamma-clone reagent is intended for the detection of the S (MNS3) antigen on red blood cells by tube test.

  IMMUCOR, INC.

  2022-04-22

• Capture-R Ready-Screen (I and II) - Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods.

  IMMUCOR, INC.

  2016-04-14

• Capture-R Ready-Screen (I and II) - Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains alternating wells coated with red blood cell membranes from one of two group O donors. Each strip consists of eight (8) individual wells to perform four (2-cell) antibody screens. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.

  IMMUCOR, INC.

  2016-06-04

• Capture-R Ready-ID Extend I - Capture-R Ready-ID Extend I is intended for use in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. The double-strip configuration is composed of 2 x 8 strips which contain test wells coated with D-positive red cell membranes of 14 group O single donors.

  IMMUCOR, INC.

  2016-06-04

• Capture-R Ready-ID Extend I - Capture-R Ready-ID Extend I is intended for use in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. The double-strip configuration is 2 x 8 strips containing test wells coated with D-positive red blood cell membranes of 14 group O single donors. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.

  IMMUCOR, INC.

  2016-06-04

• Capture-R Ready-ID Extend II - Capture-R Ready-ID Extend II is intended for use in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. The double-strip configuration is composed of 2 x 8 strips which contain test wells coated with D-negative red blood cell membranes of 14 group O single donors.

  IMMUCOR, INC.

  2016-06-04

• Capture-R Ready-ID Extend II - Capture-R Ready-ID Extend II is intended for use in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. The double-strip configuration of this product is 2 x 8 strips which contain test wells coated with D-negative red cell membranes of 14 group O single donors. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.

  IMMUCOR, INC.

  2016-06-04

• Capture-R® Ready-Screen® (I and II) - Capture-R Ready-Screen (I and II) is used in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains alternating wells coated with red blood cell membranes from one of two group O donors. Each strip consists of eight (8) individual wells to perform four (2-cell) antibody screens.

  IMMUCOR, INC.

  2014-09-24

• Capture-R Ready-Screen (Pooled Cells) - Capture-R Ready-Screen (Pooled Cells) is used in the detection of unexpected IgG antibodies to red blood cells (in blood donors) by manual, semi-automated or automated solid phase red blood cell adherence methods. Each test well is prepared from a pool of two (2) group O donors. Each microplate strip consists of eight (8) individual wells to perform eight (8) antibody screens. Each microplate is packaged into a pouch.

  IMMUCOR, INC.

  2016-06-04

• Capture-R Ready-ID - Capture-R Ready-ID is used in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product is a double-strip configuration which carry the bound and dried membranes prepared from 14 group O donors. Each microplate contains six (6) double-strips, and the plate is sealed in a pouch.

  IMMUCOR, INC.

  2016-06-04

• Capture-R® Ready-Screen® (I and II) - Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. The product contains alternating wells coated with red blood cell membranes from one of two group O donors. Each strip consists of eight (8) individual wells to perform four (2-cell) antibody screens. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.

  IMMUCOR, INC.

  2014-09-24

• Capture-R Ready-Screen (Pooled Cells) - Capture-R Ready-Screen (Pooled Cells) is used in the detection of unexpected IgG antibodies to red blood cells (in blood donors) by manual, semi-automated or automated solid phase red blood cell adherence methods. Each test well is prepared from a pool of two (2) group O donors. Each microplate strip consists of eight (8) individual wells to perform eight (8) antibody screens. Each microplate is packaged into a pouch. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.

  IMMUCOR, INC.

  2016-06-04

• Capture-R Ready-ID - Capture-R Ready-ID is used in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product is a double-strip configuration which carry the bound and dried membranes prepared from 14 group O donors. Each microplate contains six (6) double-strips, and the plate is sealed in a pouch. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.

  IMMUCOR, INC.

  2016-06-04

• Capture-R Ready-Screen (I and II) - Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains alternating wells coated with red blood cell membranes from one of two group O donors. Each strip consists of eight (8) individual wells to perform four (2-cell) antibody screens. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.

  IMMUCOR, INC.

  2016-06-04

• Capture-R Control set - Capture-R Control set (Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum) are run controls to be used in Capture-R solid phase assays. The Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells. The Capture-R Negative Control Serum does not contain antibodies to red blood cells. This product configuration has one (1) vial of each control, at a volume of 11.5 mL each.

  IMMUCOR, INC.

  2016-04-18

• Capture-R Ready-Screen (Pooled Cells) - Capture-R Ready-Screen (Pooled Cells) is used in the detection of unexpected IgG antibodies to red blood cells (in blood donors) by manual, semi-automated or automated solid phase red blood cell adherence methods. Each test well is prepared from a pool of two (2) group O donors. Each microplate strip consists of eight (8) individual wells to perform eight (8) antibody screens. Each microplate is packaged into a pouch. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.

  IMMUCOR, INC.

  2016-06-04

• Capture-R Ready-Screen (4) - Capture-R Ready-Screen (4) is used in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains four (4) test wells coated with red blood cell membranes. Each strip consists of two antibody screens, i.e. two (2) sets of four (4) wells. Each microplate contains twelve (12) strips. Each microplate is packaged into a pouch.

  IMMUCOR, INC.

  2016-06-04

• Capture-R Ready-Screen (3) - Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains three (3) test wells coated with red blood cell membranes from three (3) group O donors, as well as a positive control well, which all make up one (1) test of four (4) wells. Each strip consists of two antibody screens, i.e. two (2) sets of four (4) wells. Each microplate contains twelve (12) strips. Each microplate is packaged into a pouch.

  IMMUCOR, INC.

  2016-06-04

• Capture-R Ready-Screen (3) - Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains three (3) test wells coated with red blood cell membranes from three (3) group O donors, as well as a positive control well, which all make up one (1) test of four (4) wells. Each strip consists of two antibody screens, i.e. two (2) sets of four (4) wells. Each microplate contains twelve (12) strips. Each microplate is packaged into a pouch.

  IMMUCOR, INC.

  2016-06-04

176 records. Showing 1-40. Next