Clinical Data Validating ZipThaw
ZipThaw is the New Thawing Standard of Care
Universities, labs, clinics and multiple regulatory agencies have conducted extensive clinical studies of ZipThaw. Please review the clinical data indicating ZipThaw is the new thawing standard of care.
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ISO 13485 Certification
Our primary manufacturing quality certification and regulatory standards followed
AABB Certification
AABB Quality Standards designation, ZipThaw is the only such device registered with AABB
UL Device Certification
UL Safety designation, supported by extensive testing against UL safety standards
UL Labels and MDR compliance
UL confirmation of compliance to EUDAMED UDI and MDR standards for device and packaging labels
Medical Device and Equipment Risk Assessment (MDERA), US Government Cyber Security Certification
Complex process to prove ZipThaw202 meets all government standards for security or donor or patient data or information, including any data transmission
ZipThaw Plasma Thawing studies to FDA for 510k – Coagulation Factors analysis through San Diego Blood Bank and UCSD laboratories
Primary studies to test ZipThaw202 against a known water bath predicate device, for 510k submission, pre- and post- thaw testing for 9 FDA designated coagulation factors, to a defined performance of no less than 20% loss of factor potency
Impact of Using a Dry Plasma Thawer for Frozen Red Blood Cell Preparation, Dr Meledeo, US Army Institute of Surgical Research, JBSA-FT Sam Houston
Study comparing ZipThaw202 to a known predicate device (water bath), for thawing of Haemonetics prepared units of frozen red blood cells, demonstrating ZipThaw was as good or better than the predicate device, data to be submitted to FDA to extend intended use
Comprehensive Cell Solutions (NYBC) Thawing Cryopreserved Apheresis sourced cell products
Study of 3 apheresis white blood cell collections sourced from clinical donors, compared predicate water bath performance for cell recovery and viability, found ZipThaw to be suitable for thawing this type of cell therapy products
Efficacy of Thawing CCP - Immunoglobulins, tested for IgM, IgA and IgG
Study to demonstrate that the ZipThaw202 is well suited for quick and reliable thawing of covid convalescent plasma for critically ill Covid patients, while maintaining full immunoglobulin yields
mRNA recovery testing intended to show ZipThaw could thaw Covid mRNA vaccines
Study to demonstrate that the ZipThaw202 is well suited for quick and reliable thawing of materials containing mRNA, as would be found in various Covid vaccines, while preserving mRNA yields
CellPhire study assessment for thawing of Cryopreserved Platelets
study demonstrating ZipThaw, as a dry thawing system, is compatible with quickly and reliably thawing of Cryopreserved Platelets
Validation of MELT Configuration for Cryopreserved Hematopoietic Progenitor Cell Products:
A Paired Comparison with 37°C Water Bath, Georgetown, Dr. Cui, Wanxing, demonstrated statistical superiority in thawing selected cell therapy products, as a standardized thawing method