INCELL currently has various types of registrations, licenses and certifications related to the storage, processing, manufacturing, testing and distribution of regenerative medicine cell and tissue products and is seeking others.
- Human Cell and Tissue Products (HCT/Ps): Manufacturing, Banking, Distribution
- USA registration with Center for Biologics Evaluation and Research (CBER) FDA;
https://www.fda.gov/cber/tissue/tisreg.htm Establishment FEI#3004107906
INCELL_HCTP_Registration_FDA3356_FEI3004107906A2015A.pdf (11.7 KiB, 1,105 hits) - State Tissue Bank registrations and licenses:
- Active Annual 2015-2016 Registrations
*Delaware
*Illinois
*Oregon - Licenses
*Florida License #245 (Through 2-24-2017)
*Pending Applications: California; New York
- Active Annual 2015-2016 Registrations
- American Association of Tissue Banks (AATB)
- National Facility Certification in Review
- Certified Tissue Banking Specialists (CTBS); 2015: Certified three senior managers:
- USA registration with Center for Biologics Evaluation and Research (CBER) FDA;
- Medical device manufacturer registered with Center for Devices and Radiological Health (CDRH) FDA;
https://www.fda.gov/medicaldevices ; Focus on sterile liquid fill products- Establishment Registration Number: 3004107906
- Owner Operator Number: 9057577
Other Registrations Licenses & Certifications can be found here.