Infectious Disease Tests

The following products are regulated as Infectious Disease Tests:

Infectious Disease Tests with Supporting Documents

• Elecsys Chagas
• Hepatitis B
• Hepatitis C
• HIV-1
• HIV-1/2
• Human T-Lymphotropic Virus Types I & II
• Malaria
• Procleix Babesia Assay
• Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay)
• West Nile Virus (WNV)
• Zika

---

Related Information

• Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
• Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases