21 CFR 862.1795 — Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1795

Identification

A vanilmandelic acid test system is a device intended to measure vanilmandelic acid in urine. Measurements of vanilmandelic acid obtained by this device are used in the diagnosis and treatment of neuroblastoma, pheochromocytoma, and certain hypertensive conditions.

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
CDFAcid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin112
CDKAcid, Vanilmandelic, Electrophoretic Separation10
Innolitics

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