RADIAS PHENYLALANINE TEST

• K Number: K960437
• Device Name: RADIAS PHENYLALANINE TEST
• Manufacturer: BIO-RAD
• Date Cleared: 1996-08-16 ( 198 days)
• Product Code: JNB
• Regulation Number: 862.1555
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Summary

Loading...

Regulation Number and Section

§ 862.1555 Phenylalanine test system.

(a)
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.(b)
Classification. Class II.