Product Approval Information - Licensing Action
Proper name: Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived)
Tradename: COBAS Ampliscreen HCV
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: 5/13/2004
Type of submission: Biologics license application supplement
Approval Letter -
(Text)
Label -
(PDF Part 1),
(PDF Part 2)
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