Product Approval Information
Proper Name: Human T-Lymphotropic Virus Types I and II
Tradename: ABBOTT PRISM HTLV-I/HTLV-II
Manufacturer: Abbott Laboratories, License #0043
Package Insert (PDF - 402 KB) - Approved: January 16, 2008
Date: January 16, 2008
Indication: To be used as a screening test for individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HTLV-I/HTLV-II. It is also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating.
January 16, 2008 Approval Letter