21 CFR 862.1555 — Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1555

Identification

A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine2153rd Party
JNCColumn Or Paper Chromatography Plus Ninhydrin, Phenylalanine203rd Party
Innolitics

Panel 1

/
Sort by
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from Submissions

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...