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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit

Proper Name: Abbott RealTime HIV-1 Amplification Reagent Kit, 
                     Abbott RealTime HIV-1 Calibrator Kit,
                     Abbott RealTime HIV-1 Control Kit 
Tradename:
None
Manufacturer:
 ABBOTT Molecular, Inc
Indication:

  • Quantitation of Human Immunodeficiency Virus type 1 (HIV- 1) on the automated m2000 System in human plasma for use in conjunction with clinical presentation and other laboratory markers
 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002