Micro Typing Systems A/B; MTS A/B/D; MTS A/B/D/Reverse and MTS Monoclonal Rh Phenotype Card

STN: 103756
Proper Name: Blood Grouping Reagent Combination Kit
Tradename: MTS A/B; MTS A/B/D; MTS A/B/D/Reverse and MTS Monoclonal Rh Phenotype Card
Manufacturer: Micro Typing Systems, Inc,
Indication:

• In Vitro Blood Banking Reagent
• For in vitro diagnostic use only
• For the detection of D, C, E, c and e antigens on red blood cells
• For use with the ID-Micro Typing System™
• Contains: 6 tests per card

Product Information

• Package Insert - Interpretation Guide ID Micro Typing System (103461/5118, et al.)
• Package Insert - MTS Monoclonal Rh Phenotype Card
• Package Insert - MTS A/B/D Monoclonal Grouping Card
• Package Insert - MTS A/B Monoclonal Grouping Card
• Package Insert - A/B/D Monoclonal and Reverse Grouping 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.)
• Supporting Documents older than three years - Blood Grouping Reagent Combination Kit