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Phenylalanine UV Kinetic Test Kit

by Biochemicals, Inc.

510(k) K813171

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK813171 Date3 Dec 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JNB
Device Class
Class II
Regulation
21 CFR Part 862.1555
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

The Phenylalanine UV Kinetic Test Kit provides a convenient fluorometric means to measure L-phenylalanine in biological samples. In the assay, L-phenylalanine is oxidized by phenylalanine dehydrogenase, producing NADH, which reduces a fluorescent dye to a highly fluorescent product. The kit is sufficient for 100 fluorometric tests.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Phenylalanine UV Kinetic Test Kit used for?

    The kit is intended to measure free phenylalanine in serum, plasma, and urine. These measurements aid in the diagnosis and treatment of congenital phenylketonuria, a condition that can lead to mental retardation if untreated.

  • How many tests can be performed with one Phenylalanine UV Kinetic Test Kit?

    The kit provides sufficient reagents for 100 fluorometric tests, as stated in the specifications, making it suitable for moderate-volume laboratory use.

  • What method does the Phenylalanine UV Kinetic Test Kit use to measure phenylalanine?

    The kit uses a fluorometric method where L-phenylalanine is oxidized by phenylalanine dehydrogenase, producing NADH, which then reduces a fluorescent dye to a highly fluorescent product for detection.