21 CFR 862.1115 — Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1115

Identification

A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)15
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