21 CFR 862.1580 — Phosphomolybdate (Colorimetric), Inorganic Phosphorus

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1580

Identification

A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

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 the limitations in § 862.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus1105
Innolitics

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