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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
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Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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