We put safety at the top of the list
BIOVANCE•3L tissue procurement and processing practices meet high safety standards.
Tissue used in processing BIOVANCE•3L:
- Has been procured, processed, and tested in accordance with standards established by the American Association of Blood Banks (AABB) and the United States Food and Drug Administration (FDA)
- Passed safety testing for cytotoxicity, hemolysis, irritation, endotoxins, and pyrogenicity
- Utilizes a barcode tracking system for optimal safety monitoring and to enhance patient and practitioner confidence
Donor screening and testing
- Maternal health screening, including social history
- Family medical history
- Lab testing on donor blood and afterbirth for infectious diseases, including:
- HIV 1/2 Antibodies
- HIV NAT
- HTLV I/II Antibodies
- West Nile Virus NAT
- CMV Antibodies
- Hepatitis C Antibody
- Hepatitis C NAT
- Hepatitis B Core Antibody
- Hepatitis B Surface Antigen
- Hepatitis B NAT
- Antibody Screen
- Syphilis Screening Assay
- Trypanosoma cruzi (Chagas) Antibody
Registrations and Accreditations
Celularity is registered with the FDA as a tissue establishment and accredited by the AABB.
Click on the following links to review all our certifications and licenses:
American Association of Blood Banks >
Tissue Bank License – California >
Tissue Bank License – New York >
Tissue Bank License – Maryland >
Tissue Bank License – Delaware >
Tissue Bank License – Illinois >
Tissue Bank License – Oregon >
BIOVANCE•3L INDICATIONS FOR USE
BIOVANCE•3L Ocular is an allograft intended for use as a biological membrane covering that provides the extracellular matrix while supporting the repair of damaged tissue. As a barrier membrane, BIOVANCE•3L Ocular is intended to protect the underlying tissue and preserve tissue plane boundaries with minimized adhesion or fibrotic scarring. Applications include, but are not limited to, corneal and conjunctival related injuries or defects such as corneal epithelial defects, pterygium repair, fornix reconstruction, and other procedures.
CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS
BIOVANCE•3L Ocular is contraindicated in patients with a known hyper-sensitivity to BIOVANCE•3L Ocular.
If a patient has an adverse reaction related to the use of BIOVANCE•3L Ocular, immediately discontinue its use. BIOVANCE•3L Ocular should not be used on clinically infected wounds.
The pouch contents are sterile if the pouch is unopened and undamaged. Do not use if package seal is broken. Discard material if mishandling has caused possible damage or contamination. Do not resterilize.
BIOVANCE•3L Ocular must be used prior to the expiration date on the product pouch.
BIOVANCE•3L Ocular should not be used together with a collagenase product on the wound.
For product information or adverse reaction reporting, telephone 1-844-963-2273.
Please refer to the BIOVANCE•3L Package Insert for complete product information.