Email
Due Sep 12, 2025
UTAK Lot Numbers
Sep 09, 2025 05:59 PM
Dear Andrew,
To introduce myself – my name is Hannah Stone, and I am recently employed as the Commercial Support Specialist for Abacus dx; I will be a point of contact for UTAK along with Velli Stavrou.
I have a Korean customer enquiring about the current lot numbers for the below:
• 44600: blank serum
• 44600-S(500): blank serum
• 44600-WB(F): blank whole blood
Regarding the attached ICH Experiment Guide, the customer is enquiring whether the evaluation requires 6x different lot numbers. If yes, are you able to provide an indication of how often new lots are developed?
The customer is also requesting CoA’s for the above items. Given that these are blank matrices, am I correct to assume they have no CoA?
Outcome: Needs Follow-up