Performing Lab
Quest Diagnostics
Collection Information
Processing Information - Lab Use Only
Comments
On May 3, 2007 Quest Diagnostics Laboratory was notified by Meretek, the manufacturer of the Urea Breath Test (UBT) assay, that the FDA will no longer allow this testing to be performed on patients less than 18 years of age. Previously Meretek had provided software to calculate results for pediatric samples. The FDA has decided not to clear this application and Meretek is voluntarily withdrawing the software.
Revised
05-15-07