MAGLUMI 2000 25-OH Vitamin D

Basic Information

• Brand Name: MAGLUMI 2000 25-OH Vitamin D
• Primary DI: 06947145578060
• Version / Model: 130611007M
• Catalog Number: 130611007M
• Company Name: Shenzhen New Industries Biomedical Engineering Co., Ltd.
• Labeler DUNS: 421745241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-17
• Public Version: 1
• Public Version Date: 2023-05-25
• Public Version Status: New
• Public Device Record Key: cb6b54e6-fb8a-4baf-976a-7c1ad2524371

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
MRG	System, Test, Vitamin D	Clinical Chemistry	862.1825	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60922	Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen, using a chemiluminescent immunoassay.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06947145578060	GS1

Premarket Submissions

Submission Number	Supplement Number
K191499	000

Storage Conditions

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