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Home » FDA APPROVES ABBOTT'S ARCHITECT AUSAB REAGENT KIT, CALIBRATORS AND CONTROLS
FDA APPROVES ABBOTT'S ARCHITECT AUSAB REAGENT KIT, CALIBRATORS AND CONTROLS
The FDA's Center for Devices and Radiological Health (CDRH) granted pre-market approval (PMA) for Abbott's Architect Ausab Reagent Kit, Architect Ausab Calibrators, and Architect Ausab Controls.
The Architect Ausab is a lab test used to determine if a person is, or has been, infected with the hepatitis B virus (HBV), or to determine if a patient needs to be vaccinated with the HBV vaccine. The reagent kit, calibrators and controls are used to detect antibodies associated with hepatitis B virus surface antigens (anti-HBs).
Results of the test may help a doctor determine whether a patient should be advised to receive HBV vaccine and an appropriate course of treatment, depending on the stage of HBV infection.
The FDA's approval letter may be accessed at http://www.fda.gov/cdrh/pdf5/p050051a.pdf (http://www.fda.gov/cdrh/pdf5/p050051a.pdf). The summary of safety and effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf5/p050051.html (http://www.fda.gov/cdrh/pdf5/p050051.html)
KEYWORDS FDAnews Device Daily Bulletin
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