Product Approval Information - Licensing Action
Proper name: Human Immunodeficiency Virus Type 1 (HIV-1/Polymerase Chain Reaction)
Tradename: COBAS AmpliScreen HIV-1 Test, version 1.5
Manufacturer: Roche Molecular Systems, Pleasanton, CA, License #1636
Expanded indication for use: Testing for Source Plasma donors in a mini-pool format of up to 96 donations with single unit resolution testing; and testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor’s heart is still beating)
Approval Date: 12/19/2003
Type of submission: Biologics license application supplement
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