Unilab is registered with the FDA to perform HCT/P donor eligibility testing. We have been doing this type of testing since the FDA implemented guidelines to ensure all donors are properly screened and tested for the prevention of communicable disease in May of 2005. Unilab is NOT a general FDA donor testing facility. Our focus is strictly on egg and sperm donors.
- We do NOT pool samples.
- Store all FDA donor specimens for 9 months.
- Use only FDA-licensed test kits approved and cleared for donor screening.
- Provide quarterly reports summarizing patient’s results to facilitate compliance with FDA regulations and serve as an easily accessible resource for FDA inspections.
- Immediate verbal confirmation of test results with the office in cases where a positive result is obtained.
- Expedited testing at no extra cost for emergency cases where time is critical.
- Offer web access to customized FDA donor test panels.
- All requisitions carefully reviewed to ensure required donor tests have been properly ordered.
- Offer rapid turn-around time, phlebotomy supplies and all costs related to shipping.