Galactose (without Membrane Plate) ELISA

Basic Information

• Brand Name: Galactose (without Membrane Plate) ELISA
• Primary DI: 00840239014870
• Version / Model: EIA-1487
• Catalog Number: EIA-1487
• 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: f1378d1b-6227-4893-bf81-a57db8784b79
• Distribution End Date: 2023-07-19

Device Description

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.

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	00840239014870	GS1

Customer Contacts

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

Storage Conditions

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