STN: BL 103461
Proper Name: Anti-Human Globulin
Tradename: MTS Anti-IgG Card, MTS Anti - IgG, -C3D Card
Manufacturer: Micro Typing Systems. Inc
Indication:

• In Vitro Blood Banking Reagent
• For in vitro diagnostic use
• For Direct and Indirect Antiglobulin Test
• For the detection of antigens to red blood cells
• Does not contain antibodies to complement components For use with the ID-Micro Typing System

Product Information

• Package Insert - Interpretation Guide ID Micro Typing System (103461/5118, et al.)
• Package Insert - MTS Anti-IgG Card
• Package Insert - MTS Anti-IgG Card, C3D Card

Supporting Documents

• 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