November 5, 2007
FDA clears HIV test for U.S. use
By Matthew L. Brown
The U.S. Food and Drug Administration has cleared the way for Framingham-based StatSure Diagnostic Systems Inc.'s HIV testing device to be used in clinics and doctors' offices in the United States.
The device is already used in other countries and is marketed and distributed as the Clearview Complete HIV 1/2 by Inverness Medical Innovations.
The FDA's Center for Devices and Radiological Health approved a waiver for the system to be used for the detection of HIV-1 and HIV-2 antibodies in human blood, serum and plasma.
The device is already used in other countries and is marketed and distributed as the Clearview Complete HIV 1/2 by Inverness Medical Innovations.
The FDA's Center for Devices and Radiological Health approved a waiver for the system to be used for the detection of HIV-1 and HIV-2 antibodies in human blood, serum and plasma.
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