Product Approval Information - Licensing Action
Proper name: Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus (HIV-1 and Hepatitis C Virus/ Nucleic Acid Pooled Testing/Synthetic)
Tradename: Procleix
Manufacturer: Gen-Probe, Inc, San Diego, CA, License #1592
Expanded indications for use: Testing for Source Plasma donors in a mini-pool format of up to 16 donations with single unit resolution testing; and testing individual plasma specimens from other living donors and organ donors (when specimens are obtained while the donor’s heart is still beating) and for testing individual cadaveric specimens (obtained from non-heart-beating donors)
Approval Date: 6/4/2004
Type of submission: Biologics license application supplement
Approval Letter -
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Label -
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