The DRG Galactose kit is designed for the quantitative determination of galactose in neonatal blood spots. It is for in-vitro diagnostic use as an aid in screening newborns for the elevated galactose levels as seen in galactosemia.

The DRG Galactose kit is designed for the quantitative determination of galactose in neonatal blood spots. It is for in
Galactose (with Membrane Plate) ELISA - EIA-1486

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total galactose (galactose and galactose-1-phosphate) in a clinical specimen, using a spectrophotometry method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JIA

Device Name: Enzymatic Methods, Galactose

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1310

Third Party Flag: Y

Medical Specialty: CH

Device Id: 00840239014863

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A