Accuwell

Basic Information

• Brand Name: Accuwell
• Primary DI: 00725609000199
• Version / Model: 6020-20-EGAL
• Catalog Number: 6020-20-EGAL
• Company Name: ASTORIA-PACIFIC, INC.
• Labeler DUNS: 623238615
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 4
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: f530fa16-a107-4144-b724-2479a14497c3

Device Description

Total Galactose 2000 Test Kit

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: No
• 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	00725609000199	GS1

Premarket Submissions

Submission Number	Supplement Number
K991498	000