Jean Kringstad, Director In Vitro Services

Recent Posts

WuXi AppTec Offers PTT Testing with BFT II Analysis

Posted by Jean Kringstad, Director In Vitro Services on May 22, 2018

Recently, the FDA has questioned partial thromboplastin time (PTT) that has been run on a Cascade M-4 analyzer. The FDA has concerns about the equipment’s accuracy and sensitivity, and has indicated a preference for results from a BFT II analyzer. A backlog of PTT testing has resulted since many labs do not offer BFT II analysis.

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Topics: Medical Device, Preclinical Safety, Biological Safety Testing, Regulatory, FDA, biocompatibility, hemocompatibility