BioLab Fluid GF™ is an amniotic liquid allograft derived from the amniotic fluid within the amniotic sac used to protect, lubricate and cushion. BioLab Fluid GF is solely composed of amniotic fluid and does not contain any lyophilized or micronized membrane.
BioLab Sciences has concluded that Fluid GF™️ meets the requirements for lawful marketing solely under section 361 of the Public Health Service Act (PHS Act) and 21 CFR Part 1271, including the requirements of minimal manipulation and homologous intended use.
- Product meets the definition of HCT/P
- Same surgical procedure exception does NOT apply
- Meets all 4 HCT/P criteria including
1. Minimally manipulated
2. Intended for homologous use
3. Not combined with another article
4. Is not dependent on the metabolic activity of living cells for its primary function
NOT ALL AMNIOTIC PRODUCTS ARE COVERED
Amniotic products have been effectively used in wound care since the 1930’s. However, the vast majority of them contain stem cells and are therefore deemed experimental by insurances companies. Fluid GF™ does NOT contain stem cells and was specifically given Q-Code Q4206 for the intended use of soft tissue repair and inflammation. Articles issued by CMS provide the latest instruction on coverage updates, including Q4206 as a covered HCPTS code.
Q-CODES ARE FOR SPECIFIC USE ONLY
Several Q-Codes have been issued for the coverage of amniotic products, however, most are specifically for wound care and burn healing.
Using a Q-Code for reimbursement should ONLY be done for that Q-Codes specifically documented intent ended use. CMS public records issued at the time of issuance document the Q-Codes intended approved use.
Fluid GF™ is provided in a vial as a ready to use flowable graft, with no thawing or prep required. It is stored at room temperature (50-86°F/10-30°C) until ready for use. The product has a 1-year shelf-life. Fluid GF™ is provided in an easy to apply flowable form, for precise delivery throughout the intended site.
NO ETHICAL CONCERNS
- Consenting mothers
- Scheduled cesarian births
- Fetus is untouched
- Rigorous health screenings
BioLab Sciences amniotic liquid allografts have been tested for potentially infectious diseases and terminally sterilized to ensure the safety of each liquid allograft. Each donor has been assessed for high-risk behavior and relevant diseases. The donated tissue has been deemed acceptable for transplant and all laboratories performing these tests are registered with the FDA and certified to perform testing on human specimens under CLIA and 42 CFR part 493, or equivalent requirements.