FDA REQUIREMENTS

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The FDA requires testing of all donors of HCT/Ps for the following diseases:

1. HIV – Human Immunodeficiency Virus, type 1 and type 2

2. HBV - Hepatitis B 

3. HCV – Hepatitis C

4. Treponema pallidum - syphilis

5. WNV  - West Nile Virus

6. Human T-lymphotropic virus, types I and II 

7. CMV – Cytomegalovirus 

8. Chlamydia trachomatis 

9. Neisseria Gonorrhea  

Predictive Biotech

We get our product from Predictive Biotech. They are registered with the FDA. If you would like to learn more, click the link HERE 

After Injection

We register all pertinent information after the injection and fax it to a database (per FDA requirements) to ensure the following is on record:

  • Allograft ID #
  • Lot #
  • Patient ID
  • Patient age
  • Patient sex
  • Administrating Facility