Galactose (without Membrane Plate) ELISA

Basic Information

• Brand Name: Galactose (without Membrane Plate) ELISA
• Primary DI: 00840239014894
• Version / Model: EIA-1489
• Catalog Number: EIA-1489
• Company Name: DRG International Inc
• Labeler DUNS: 075150847
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-07
• Public Version: 3
• Public Version Date: 2023-07-26
• Public Version Status: Update
• Public Device Record Key: 335269c6-0640-4d7b-a02e-69e663f8c86d
• Distribution End Date: 2023-07-19

Device Description

The DRG neonatal Galactose ELISA 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 elevated galactose levels as seen in galactosemia.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIA	ENZYMATIC METHODS, GALACTOSE	Clinical Chemistry	862.1310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59376	Total galactose IVD, kit, spectrophotometry	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840239014894	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius