grifols.comQuality Control Kits For Blood Banking Reagents
DIAGAST
DIAGAST
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006261638 | 3006261638 | DIAGAST | 1 | N | 2026-01-01 | Parc Eurasante 251, Avenue Eugene Avinee LOOS Hauts-de-France FR 59120 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 23661562105469 | Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Green - Anti-Human Globulin Anti-IgG,-C3d (Murine Monoclonal) (18833+18896+12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating on human red blood cells with IgG and/or C3d components. In addition to recognizing IgG antibodies and the complement fragment C3d, Anti Human Globulin Anti-IgG, C3d is able to recognize IgM antibodies on the surface of red blood cells since IgM antibodies always fix complement | (800) 452-6877 | service.americas@grifols.com |
| 23661562105476 | Anti-Human Globulin Anti-IgG - Green - Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for the indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test method. | (800) 452-6877 | service.americas@grifols.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission |
|---|---|---|
| 217473 | 1596381786 | BK190313 |
| 217473 | 1013611651 | BK160084 |
| 217473 | 1053507899 | |
| 217473 | 1620254646 |
PMN#
GUDID#
Beckman Coulter® PK® Systems Anti-e (P3GD512+MS63) - Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® 7300 Systems
2015-09-04
Beckman Coulter® PK® Systems Control - Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System
2016-01-12
Beckman Coulter® PK® Systems Bromelin - Red Blood Cells Diluent, formulated for Automated Systems, Beckman Coulter® PK® System
2015-09-18
Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Green - Anti-Human Globulin Anti-IgG,-C3d (Murine Monoclonal) (18833+18896+12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating on human red blood cells with IgG and/or C3d components. In addition to recognizing IgG antibodies and the complement fragment C3d, Anti Human Globulin Anti-IgG, C3d is able to recognize IgM antibodies on the surface of red blood cells since IgM antibodies always fix complement
2018-05-01
Anti-Human Globulin Anti-IgG - Green - Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for the indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test method.
2018-05-01
Anti-Human Globulin Anti-IgG - Clear - Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for the indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test method.
2018-05-01
Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Clear - Anti-Human Globulin Anti-IgG,-C3d (Murine Monoclonal) (18833+18896+12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating on human red blood cells with IgG and/or C3d components. In addition to recognizing IgG antibodies and the complement fragment C3d, Anti Human Globulin Anti-IgG, C3d is able to recognize IgM antibodies on the surface of red blood cells since IgM antibodies always fix complement
2018-05-01
Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63) - Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK®7400 Systems
2020-10-20
Anti-A (AB01) - Blood Grouping Reagent, Anti-A (Murine Monoclonal) (9113D10) - This reagent is designed to determine the presence of ABO system blood group antigen A on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-B (AB02) - Blood Grouping Reagent, Anti-B (Murine Monoclonal) (9621A8) - This reagent is designed to determine the presence of ABO system blood group antigen B on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-A,B (AB03) - Blood Grouping Reagent, Anti-A,B (Murine Monoclonal) (152D12+9113D10) - This reagent is designed to determine the presence of ABO system blood group antigen A and B on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-D (RH1) IgG - Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal) (IgG) (HM16) - This reagent is designed to determine the presence of the blood Rhesus antigen D (RH1) on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-D (RH1) IgM - Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal) (P3X61) - This reagents are designed to determine the presence of the blood Rhesus antigen D (RH1) on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-C (RH2) - Blood Grouping Reagent, Anti-C (Human/Murine Monoclonal) (P3X25513G8+MS24) - This reagent is designed to determine the presence of the blood group antigen C (Rh2) on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-c (RH4) - Blood Grouping Reagent, Anti-c (Human/Murine Monoclonal) (951) - This reagent is designed to determine the presence of the blood group antigen c (Rh4) on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-E (RH3) - Blood Grouping Reagent, Anti-E (Human/Murine Monoclonal) (906) - This reagent is designed to determine the presence of the blood group antigen E (Rh3) on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-e (RH5) - Blood Grouping Reagent, Anti-e (Human/Murine Monoclonal) (P3GD512+MS63) - This reagent is designed to determine the presence of the blood group antigen e (Rh5) on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-Fya (FY1) - Blood Grouping Reagent, Anti-Fya (Human/Murine Monoclonal) (IgG) (DG-FYA-02) - These reagents are designed to determine the presence of the blood group antigen Fya on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-Fyb (FY2) - Blood Grouping Reagent, Anti-Fyb (Human/Murine Monoclonal) (SpA264LBg1) - This reagent is designed to determine the presence of the blood group antigen Fyb (FY2) on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-K (KEL1) - Blood Grouping Reagent, Anti-K (Human/Murine Monoclonal) (MS56) - This reagent is designed to determine the presence of the blood group antigen K on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-Jka (JK1) - Blood Grouping Reagent, Anti-Jka (Human/Murine Monoclonal) (P3HT7) - This reagent is designed to determine the presence of the blood group antigen Jka (JK1) on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-Jkb (JK2) - Blood Grouping Reagent, Anti-Jkb (Human/Murine Monoclonal) (P3.143) - This reagent is designed to determine the presence of the blood group antigen Jkb (JK2) on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-M (MNS1) - Blood Grouping Reagent, Anti-M (Murine Monoclonal) (IgG) (2514E6) - This reagent is designed to determine the presence of the blood group antigen M (MNS1) on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-S (MNS3) - Blood Grouping Reagent, Anti-S (Human/Murine Monoclonal) (IgG) (P3S13JS123) - This reagent is designed to determine the presence of the blood group antigen S (MNS3) on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-s (MNS4) - Blood Grouping Reagent, Anti-s (Human/Murine Monoclonal) (IgG) (P3YAN3) - This reagent is designed to determine the presence of blood group antigen s on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-P1 (P1) - Blood Grouping Reagent, Anti-P1 (Murine Monoclonal) (650) - This reagent is designed to determine the presence of blood group antigen P1 on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-Lea (LE1) - Blood Grouping Reagent, Anti-Lea (Murine Monoclonal) (13643B9) - This reagent is designed to determine the presence of the blood group antigen Lea (LE1) on the surface of human red blood cells by manual tube method.
2018-05-01
Anti-Leb (LE2) - Blood Grouping Reagent, Anti-Leb (Murine Monoclonal) (GX336) - This reagent is designed to determine the presence of the blood group antigen Leb (LE2) on the surface of human red blood cells by manual tube method.
2018-05-01
Neg Control - Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique
2018-05-01
LISS - Low-ionic-strength phosphate buffered saline solution ready for use to prepare human red blood cell suspensions for immunohematological testing in tube methods
2018-05-01
Papain - Papain is a ready to use stabilized solution of proteolytic enzyme, derived from papaya (Carica papaya), used to treat human red blood cells in immunohematology.Intended to be used with DIAGAST Anti-Lea (LE1) (REF 210541)
2018-05-01
Anti-Human Globulin Anti-C3d - Anti-Human Globulin Anti-C3d (Murine Monoclonal) (12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with C3d components. Anti-Human Globulin Anti-C3d only recognizes the complement fragment and, consequently, cannot react with component C4.
2018-05-01
Beckman Coulter® PK® Systems Anti-A (2521B8+16243G2) - Blood Grouping Reagent Anti-A (Murine Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
2015-09-04
Beckman Coulter® PK® Systems Anti-B (9621A8) - Blood Grouping Reagent Anti-B (Murine Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
2015-09-04
Beckman Coulter® PK® Systems Anti-AB (2521B8+16243G2+16247E10+7821D9) - Blood Grouping Reagent Anti-A,B (Murine Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
2015-09-04
Beckman Coulter® PK® Systems Anti-D (P3X61+P3X21223B10+P3X290+P3X35) - Blood Grouping Reagent Anti-D (Monoclonal Blend) formulated for Automated Systems, Beckman Coulter® PK® Systems
2015-09-04
Beckman Coulter® PK® Systems Anti-D (PK1) (P3X61) - Blood Grouping Reagent Anti-D (Monoclonal-IgM) formulated for Automated Systems, Beckman Coulter® PK® Systems
2015-09-04
Beckman Coulter® PK® Systems Anti-D (PK2) (HM10) - Blood Grouping Reagent Anti-D (Monoclonal-IgM) formulated for Automated Systems, Beckman Coulter® PK® Systems
2015-09-04
Beckman Coulter® PK® Systems Anti-E (906) - Blood Grouping Reagent Anti-E (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
2015-09-04
Beckman Coulter® PK® Systems Anti-C (P3X25531G8+MS24) - Blood Grouping Reagent Anti-C (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
2015-09-04