OLYMPUS PK Systems Blood Grouping and Phenotyping Reagents
STN: 125168 - 125177, 125187
Proper Name: OLYMPUS PK Systems Blood Grouping and Phenotyping Reagents
Tradename: Blood Grouping Reagents
Manufacturer: DIAGAST
Indication:
- The PK SYSTEM REAGENT RED BLOOD CELLS (A1 and B) are intended for the determination of the reverse or plasma group on the BECKMAN COULTER PK7300 and PK7400 Automated Microplate System(s).
- The PK SYSTEM BLOOD GROUPING REAGENTS AND PK SYSTEM CONTROL are intended for the determination of ABO blood group, Rh and Kell phenotypes in blood donors using the BECKMAN COULTER PK7300 and/or the BECKMAN COULTER PK7400 Automated Microplate Systems(s).
- The Anti-A, Anti-B, and Anti-A,B reagents are used in the red blood cell determination of the ABO blood group. They are used to determine the absence or presence of erythrocytic antigens A and/or B on the surface of human red blood cells.
- The Anti-D Reagents: Anti-D, Anti-D (PK1), Anti D (PK2), are used to determine the Rh (D) type. They are used to detect the presence of the Rh(D) antigen on the surface of human red blood cells.
- The Anti-C, Anti-E, Anti-c, Anti-e, and Anti-K are used for Rh Subgroups and Kell phenotyping of human red blood cells. These reagents detect presence of antigens C, E, c, e, and K on the surface of red blood cells. The CONTROL is devoid of antibody activity and should be used in parallel testing with the PK SYSTEM BLOOD GORUPING REAGENTS to differentiate between specific and non-specific agglutination.
Product Information
- Package Insert - Reagent Red Blood Cells A1 Cells / B Cells (BL 125168)
- Package Insert - Blood Grouping Reagent Anti-e P3GD512 + MS16 + MS21 + MS63 (BL 125176)
- Package Insert - Blood Grouping Regents Anti-A, Anti-B, Anti-A,B, Anti-D, Anti-D (PK 1), Anti-D (PK 2), Anti-C, Anti-E, Anti-c, Anti-e, and Anti-K (BL 125169 - 125175, 125177, 125186)
Supporting Documents
- May 7, 2020 Approval Letter - Reagent Red Blood Cells A1 Cells / B Cells (125168)
- May 7, 2020 Approval Letter - Blood Grouping Reagent Anti-e P3GD512 + MS16 + MS21 + MS63 (BL 125176)
- May 7, 2020 Approval Letter - Blood Grouping Regents Anti-A, Anti-B, Anti-A,B, Anti-D, Anti-D (PK 1), Anti-D (PK 2), Anti-E, Anti-e, Anti-C, Anti-c, and Anti-K (BL 125169 - 125175, 125177, 125186)
- Supporting Documents older than three years - OLYMPUS PK Systems Blood Grouping and Phenotyping Reagents