Clearance for Extended HDL Range Lipid Panel Test Strips | 合法醫療器材資訊網

2019年6月10日—PTSDiagnosticsAnnouncesNewFDA510(k)ClearanceforExtendedHDLRangeLipidPanelTestStrips...ThePTSPanelslipidpanelteststripnow ...

Indianapolis, IN – DATE – PTS Diagnostics, the US-based manufacturer of point-of-care biometric testing devices, announced today that the US Food and Drug Administration (FDA) has cleared1 an expanded top range for measurement of HDL cholesterol (HDL) to 120 mg/dL (3.1 mmol/L) for the company’s PTS Panels® lipid panel test strips. The PTS Panels lipid panel test strip now has a measurement range of 20 to 120 mg/dL (0.52 to 3.1 mmol/L) for HDL. Additionally, the lipid panel shelf life has increased due to the use of new test strip vials.