Package Inserts

The following package inserts contain instructions for performing common tests supported by LABS. Per FDA requirements, package inserts are sent with each test kit provided by LABS.

• Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products:Posted 2/27/07
• FDA Approved Donor Screening Tests for HCT/Ps
• 21 CFR Part 1271 Compliance Summary Table
• ABO/Rh TANGO System
• Chagas IgG Antibody
• CMV IgG Antibody
• CMV IgM Antibody
• CMV Total Antibody
• Chlamydia/GC Aptima TMA
• Epstein Barr Virus IgG
• Epstein Barr Virus IgM
• Flourescent Treponema Antibody
• HBV NAT PCR
• HCV NAT PCR
• Hepatitis A Antibody
• Hepatitis B Core Antibody
• Hepatitis B Core IgM Antibody NEW KIT
• Hepatitis B Core IgM Antibody
• Hepatitis B Surface Antibody
• Hepatitis B Surface Antibody NEW KIT
• Hepatitis B Surface Antigen
• Hepatitis B Surface Antigen Neutralization
• Hepatitis C Antibody (Abbott)
• Hepatitis C Antibody (Ortho)
• Hepatitis C RIBA
• Herpes Simplex Virus IgG
• Herpes Simplex Virus IgM
• HIV 1/2 Antibody
• HIV-1 NAT PCR
• HIV-1 Western Blot
• HIV-1/HCV NAT TMA
• HTLV-I and II Antibody (Abbott)
• HTLV-I and II Antibody (Biomerieux)
• RPR ASI NEW KIT
• RPR BD
• STS
• TOXO IgG Antibody
• WNV NAT TMA