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.


WHAT TYPE OF CONDITIONS ARE TREATABLE WITH FLUID GF™?

The biologic components of Fluid GF™ are often used as part of a treatment regimen to successfully combat pain and inflammation in soft tissue. It has been shown to be an excellent modality for treating the symptoms of arthritis, plantar fasciitis, and tendonitis.

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COVERED BY INSURANCE, INCLUDING MEDICARE

BioLab Fluid GF™ has been issued Q-Code: Q4206 for the following intended use:

“The patient population indicated for use of Fluid GF™ include acute and chronic wounds and soft tissue injury, muscle and meniscus tears, ligament and tendon sprains, degenerative tissue disorders and inflammatory conditions (tendonitis and fasciitis).” CMS HCPCS Public Meeting, May 13, 2019

FDA COMPLIANCE

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
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Reimbursement Guarantee

BioLab Sciences and EMS Bio offer support to your billing department in securing reimbursements. If for any reason the insurance denies the claim, we will go to work on your behalf.

BioLab Sciences is so confident in this process that we offer a Reimbursement Guarantee that replaces the product used, free of charge, if you are denied reimbursement.

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. 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.