MTS Anti-IgG, -C3d Card

STN: BL 103461 Proper Name: Anti-Human Globulin Tradename: MTS Anti-IgG, -C3d Card; Anti-IgG (Rabbit)/Anti-C3b,-C3d (Murine Monoclonal)/DAT Control, MTS DAT Card Manufacturer: Micro Typing Systems. Inc Indication: Anti-IgG (Rabbit)/Anti-C3b,-C3d (Murine Monoclonal)/DAT Control, MTS™ DAT Card indicated for: In vitro diagnostic and laboratory professional use Qualitative procedure for the detection of IgG or C3 components of complement bound to red blood cells. For use with the ID-Micro Typing System™ For the testing of 1 to 2 samples per gel card Anti-Human Globulin Anti-IgG (Rabbit)/Anti-C3b, -C3d (Murine Monoclonal)/DAT Control, MTS™ DAT Card is intended for the detection of antibodies and or complement on human red blood cells using the direct antiglobulin test. This direct antiglobulin test allows for the differentiation of human red blood cells sensitized in vivo by IgG type immunoglobulins or complement C3b and or C3d fractions. Blood samples from patients and or donors intended for direct antiglobulin testing should be drawn into EDTA to prevent in vitro complement binding. MTS™ DAT Card is intended for manual or automated column agglutination technology using ORTHO® Workstation, and the ORTHO VISION® and VISION® Max Analyzers Qualitative procedure for the detection of IgG or complement bound to red blood cells for use with the ID-Micro Typing System. Product Information Package Insert - Anti-IgG (Rabbit)/Anti-C3b,-C3d (Murine Monoclonal)/DAT Control, MTS DAT Card - 103461/5128 Package Insert - Interpretation Guide ID Micro Typing System (103461/5118, et al.) Package Insert - MTS Anti-IgG Card Package Insert - MTS Anti-IgG, -C3d Card Supporting Documents October 10, 2025 Approval Letter - Anti-C3b,-C3d (Murine Monoclonal)/DAT Control, MTS DAT Card - 103461/5128 January 28, 2025 Approval Letter - MTS Anti-IgG, -C3d Card June 3, 2022 Approval Letter – Anti-Human Globulin and Blood Grouping Reagent (BL 103461/5118, et.al) March 10, 2021 Approval Letter - Anti-Human Globulin (BL 1034615114) and Blood Grouping Reagent (103756/5095 et al.) December 17, 2019 Approval Letter - MTS Anti-IgG Card July 8, 2019 Approval Letter - MTS Anti-IgG Card