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  


To learn more about their serological test, click HERE

Surgenex

We get our product from Surgenex. If you'd like to learn more about how they work with the FDA, click 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