21 CFR 862.1770 — Berthelot Indophenol, Urea Nitrogen

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1770

Identification

A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
CDLBerthelot Indophenol, Urea Nitrogen2163rd Party
CDNUrease, Photometric, Urea Nitrogen2163rd Party
CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen21173rd Party
CDSElectrode, Ion Specific, Urea Nitrogen2153rd Party
CDWDiacetyl-Monoxime, Urea Nitrogen2213rd Party
JGZO-Phthalaldehyde, Urea Nitrogen2113rd Party
LFPConductivity Rate, Urea Nitrogen263rd Party
Innolitics

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