TESTING SERVICES
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Infectious Disease Testing
CLIA certified laboratories provide donor eligibility screening tests for all relevant transmissible associated diseases identified by the FDA in 21CFR 1271. All equipment, assays and reagents are validated and only FDA licensed reagents are used for donor screening.
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Release Testing
Product release testing including USP 71 compliant sterility and bioburden, USP 85 compliant Endotoxin, and USP 63 compliant Mycoplasma are available.
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Donor Suitability Testing
Donor suitability including complete metabolic profiles, Zika Virus Nucleic Acid Testing, Hepatitis A Antibody, Hepatitis E Antibodies, Babesia microti, Visceral leishmaniasis, Epstein Bar Virus, HSV 1/2, HHV 6, HHV7, HHV8, Parvovirus B19, and C- Reactive Protein are available through our CLIA certified referral laboratory.