Vaccines, Blood & Biologics
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Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) Assay
Proper Name: Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay
Tradename: None
Manufacturer: BioLife Plasma Services, L.P,
Indication:
- Detection of Human Immunodeficiency Virus RNA in Human Source Plasma samples by PCR
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Supporting Documents
January 31, 2007 Approval Letter - Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay HIV - Nucleic Acid Testing - Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay - Summary of Basis for Approval (PDF - 59KB)
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