(258 days)
The N-Assay TIA Haptoglobin Test Kit is intended to be used for the quantitation of haptoglobin in human serum by immunoturbidimetric assay. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.
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§ 866.5460 Haptoglobin immunological test system.
(a)
Identification. A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.