Guardion
IMPORTANT NOTICE
For Research Use Only (RUO). Not intended for use in diagnostic procedures. Not intended for human clinical use, including in vitro fertilization (IVF) or assisted reproductive technology (ART) applications. This product has not been cleared or approved by the U.S. Food and Drug Administration for use as a medical device.
Guardion is laboratory equipment intended solely for research, process development, and agricultural applications. It is not intended for the preservation of blood or blood products for transfusion or therapeutic use in humans, nor for the cryopreservation of human reproductive cells or embryos.
LifeChain
Regulatory Notice
LifeChain is general-purpose workflow management software. It is not cleared or approved by the U.S. Food and Drug Administration as a medical device, and it is not intended for use as Blood Establishment Computer Software (BECS) as defined under 21 CFR 606.
LifeChain may be used within validated cGMP environments as part of a facility’s broader quality management infrastructure, subject to the customer’s own validation and qualification requirements. Customers are responsible for validating LifeChain in accordance with their applicable regulatory requirements, including 21 CFR Part 11 compliance where applicable.
LifeChain is not intended for:
- Donor eligibility determination
- Blood product release decisions for human clinical use
- Compliance with 21 CFR 606 blood establishment requirements
- Management of products intended for human transfusion or implantation
Email [email protected] should you have a enquiries about our first generation unit, VCU1.