21 CFR 862.1187 — Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1187

Identification

A conjugated sulfolithocholic acid (SLCG) test system is a device intended to measure the bile acid SLCG 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
KWXRadioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids223rd Party
Innolitics

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