(64 days)
The Randox Laboratories Limited Magnesium Test Kit is an in vitro diagnostic reagent for the quantitative determination of magnesium in human serum or plasma. This method uses Xylidyl Blue to measure magnesium. Abnormal concentrations of magnesium (elevated or low) are associated with a variety of clinical conditions.
This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
in vitro diagnostic reagent for the quantitative determination of magnesium in human serum or plasma. This method uses Xylidyl Blue to measure magnesium.
I am sorry, but the provided text only contains an FDA clearance letter for the Randox Magnesium Test Kit (K974606) and a page detailing its indications for use. It does not include acceptance criteria, study details, or performance data for the device. Therefore, I cannot fulfill your request for the information outlined.
§ 862.1495 Magnesium test system.
(a)
Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).(b)
Classification. Class I.