21 CFR 862.1177 — Radioimmunoassay, Cholyglycine, Bile Acids

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1177

Identification

A cholylglycine test system is a device intended to measure the bile acid cholylglycine in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KWWRadioimmunoassay, Cholyglycine, Bile Acids263rd Party
Innolitics

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