Abbott/Murex
This article was originally published in The Gray Sheet
Executive Summary
The only rapid HIV test available on the U.S. market, the Abbott Murex Single Use Diagnostic System HIV-1 test, resumes availability after a seven months hiatus, FDA Center for Biologics Evaluation and Research announces May 10. Production was halted in October 2000 after a failure to meet certain panel and negative control specifications. After adding supplemental testing to ensure the product met its quality control specifications, CBER determined that five consecutive lots of the SUDS HIV-1 tests Abbott submitted could be released for clinical use