(63 days)
This device is intended for the quantitative determination of direct bilirubin in serum or plasma. Bilirubin is an organic compound formed during the catabolism of red blood cells and its measurement is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
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The provided text is a 510(k) premarket notification letter from the FDA regarding a "Direct Bilirubin Reagent." This document is an approval letter for a medical device and does not contain information about acceptance criteria, study details, or performance metrics.
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§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.