(88 days)
The FastPack® TSH Immunoassay is a paramagnetic particle immunoassay for the in-vitro quantitative determination of TSH in human serum or plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. FastPack® TSH Immunoassay is designed for use with the FastPack® System.
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§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.