This article was originally published in The Gray Sheet
Rapid HIV-1 antibody test is deemed "approvable" by FDA pending resolution of "specific validation and control issues" detected during a recent agency inspection of the firm's manufacturing facilities, OraSure announces May 13. The test can detect HIV-1 antibodies in whole blood via a finger stick within 20 minutes (1"The Gray Sheet" May 6, 2002, p. 42). A market launch is slated for the second half of the year...
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