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In Brief: Coulter Corp.

This article was originally published in The Gray Sheet

Executive Summary

Coulter Corp.: Anticipates approval "very soon" for its Coulter HIV-1 p24 antigen assay for use in blood donor screening. The Miami-based firm says it has submitted all the data requested by the agency since receiving its "approvable letter" in August 1995 ("The Gray Sheet" Aug. 14, 1995, p. 12), including stability and product labeling information. Ortho Diagnostic Systems has exclusive worldwide rights to market the test for screening indications. The test will be run on Ortho's automated Summit system, which already is used with microplate format screening tests for HIV-1, Hepatitis and other diseases...
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