FDA Logo links to FDA home page
Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

horizontal rule
CBER links to product areas Blood Vaccines Cellular/Gene Therapy Tissue Devices
CBER links Products Industry Healthcare Reading Room Meetings What's New
horizontal rule

Premarket Approval Information - Devices

horizontal rule

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

horizontal rule

Letter - (Text)

Label - (PDF)

Summary - (PDF)

 

Updated April 29, 2002
 
horizontal rule

CBER Home Page | CBER A-Z Index | CBER Search | Contact CBER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA / Center for Biologics Evaluation and Research