FDA’s expanded indication for Chembio’s POC testing
The U.S. Food and Drug Administration has given approval to Chembio Diagnostics, Inc. to extend the age range for its HIV rapid point-of-care testing by lowering the age limit to 13 years and above from 18 years. The Laboratory of Viral Diagnostics, University of Maryland School of Medicine, conducted a clinical study and recommended the expansion of age limit on the basis of the study’s findings. The test can be carried out in primary care settings.
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