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Premarket Approval Information - Devices

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Product: NucliSens HIV-1 QT
Applicant: bioMerieux, Inc., Durham, NC
PMA number: BP010001/0
Indication for Use: in conjunction with clinical presentation and other laboratory markers of disease progression for prognostic assessment of HIV-1 infected patients, and for monitoring the effects of anti-retroviral therapy by serial measurements of plasma HIV-1 RNA for pediatric and adult patients with baseline viral loads greater than 93,000 and 28,000 copies of HIV-1 viral RNA/mL respectively
Approval Date: 11/19/2001

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Letter - (Text)

Label - (PDF)

Summary - (PDF)

 

Updated April 29, 2002
 
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