Alpha-2-glycoproteins immunological test system.

21 C.F.R. § 866.5425
in effectEffective: 2024-07-01
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(a) Identification. An alpha-2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-glycoproteins (a group of plasma proteins found in the alpha-2 group when subjected to electrophoresis) in serum and other body fluids. Measurement of alpha-2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

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