Biosite Diagnostics' Triage cardiac panal:
This article was originally published in Clinica
Biosite Diagnostics has received the final three 510(k) approvals that will allow it to launch its Triage cardiac panel. The FDA has cleared both the quality and calibration verification controls, and the Triage meter which is used in conjunction with the system. The cardiac panel is used to measure three cardiac markers - creatinine kinase (CK-MB), myoglobin and troponin I - in whole blood samples. Rising levels of these markers have been shown to be indicative of a heart attack.
You may also be interested in...
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Among the largest gaps in safety data is non-clinical research on CBD use's effect on developing fetus and adolescent brain, in utero/lactational exposure, reproductive toxicity and the potential for a latency period before toxicity, says FDA neuroscientist Andrew Shen.
The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.