DG Gel Card 125445, 125449, 125450 - 125457

STN#:  125445, 125449, 125450, 125451, 125452, 125453, 125454, 125455, 125456, 125457
Proper Name: Blood Grouping Reagent Combination Kit
Tradename: DG Gel Card
Manufacturer: Diagnostic Grifols, S. A.
Indication:

• DG Gel 8 AB (x4) card is for the determination of human A and B antigen on the surface of red blood cells in four separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
• DG Gel 8 A/B/D card is for the determination of human A, B and D antigens on the surface of red blood cells in two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
• DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse grouping, and D and Kell antigens on the surface of red blood cells in human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
• DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surface of red blood cells in two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
• DG Gel 8 T/S Mono card is for the determination of human A, B and D antigens on the surface of red blood cells, and for Indirect Antiglobulin Test in human blood samples. This assay does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use.
• DG Gel 8 Anti-IgG (Rabbit) card is for the direct and Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components. For use with the DG Gel System.
• The DG Gel 8 Anti-D card is for the determination of D antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
• Gel 8 Anti-C, Anti - E, Anti-c, Anti-e For the determination of human C, E, c, and/or e antigens on the surface of red blood cells of eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
• DG Gel 8 Anti-K card is for the determination of K antigen on the surface of red blood cells in eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
• DG Gel 8 Anti-AB card is for the determination of human A and B antigens on the surface of red blood cells of eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
• DG Gel 8 ABO/Rh card is for the determination of ABO forward and reverse group and D antigen on the surface of red blood cells, and for ABO Compatibility Test in human blood samples. For use with Manual Method. Not for use with Erytra Eflexis, Erytra or WADiana Compact. For in vitro diagnostic use.
• DG Gel 8 AB (x4) card is for the determination of human A and B antigens on the surface of red blood cells of four separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.

Product Information

• Package Insert - DG Gel 8 ABO/Rh + Kell, DG Gel Cards - STN# 125449, 125450, 125452, 125456, 125457
• Package Insert - DG Gel 8 Rh Pheno, DG Gel Cards -STN# 125451, 125453,125454, 125455 (PDF - 112KB)
• Package Insert - DG Gel 8 AB (4x), DG Gel Cards - STN# 125449, 125450
• Package Insert - DG Gel 8 T/S Mono, DG Gel Cards - STN# 125445, 125449, 125450, 125452 (PDF - 130KB)
• Package Insert - DG Gel 8 A/B/D, DG Gel Cards - STN# 125452, 125449, 125450
• Package Insert - Anti-Human Globulin DG GEL 8 ANTI-IgG (Rabbit) - STN# 125445
• Package Insert - DG Gel 8 Anti-C, Anti - E, Anti-c, Anti-e - STN# 125451, 125453, 125454, 125455
• Package Insert - DG Gel 8 Anti-D - STN# 125452
• Package Insert - DG Gel 8 Anti-K - STN# 125457
• Package Insert - DG Gel 8 Anti-AB - STN# 125456
• Package Insert - DG Gel 8 ABO/RH
• Package Insert - DG Gel 8 AB (X4)

Supporting Documents

• November 1, 2022 Approval Letter - Anti-Human Globulin DG GEL 8 ANTI-IgG (Rabbit) - STN# 125445/53
• September 29, 2021 Approval Letter - Anti-Human Globulin DG GEL 8 ANTI-IgG (Rabbit) - STN# 125445/47
• December 10, 2019 Approval Letter - DG Gel 8 Anti-IgG (Rabbit), DG Gel Cards - STN# 125445/32
• October 11, 2019 Approval Letter - DG Gel Cards - STN# 125449/55 et al.
• October 11, 2019 Approval Letter - DG Gel 8 ( Anti-Human Globulin) - STN# 125445/37
• August 12, 2019 Approval Letter - Blood Grouping Reagent, Anti-A (Murine Monoclonal) STN# 125449/44
• Supporting Documents older than three years - DG Gel Cards

Related Information

• Reagent Red Blood Cells
• Blood Grouping Regent, Anti-E (Human Monoclonal)
• Blood Grouping Reagent, Anti-D (Human Monoclonal)
• Blood Group Regent, Anti-B (Murine Monoclonal)
• Anti-Human Globulin, Anti-IgG (Rabbit Polyclonal) (FFMU)
• Blood Group Reagent Anti-c (H48)Human/Murine Monoclonal (Igm)
• Blood Grouping Reagent Anti-A (DAM1, LA2) Murine Monoclonal IgM