21 CFR 862.1730 — 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1730

Identification

A free tyrosine test system is a device intended to measure free tyrosine (an amono acid) in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as congenital tyrosinemia (a disease that can cause liver/kidney disorders) and as an adjunct to the measurement of phenylalanine in detecting congenital phenylketonuria (a disease that can cause brain damage).

Classification Rationale

Class I.

Product Codes

Product CodeDevice NameClassDevicesAttributes
CDR1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine113rd Party
Innolitics

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