MAGLUMI 2000 FT4

Basic Information

• Brand Name: MAGLUMI 2000 FT4
• Primary DI: 06947145577971
• Version / Model: 130603016M
• Catalog Number: 130603016M
• 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: 2022-08-02
• Public Version: 1
• Public Version Date: 2022-08-10
• Public Version Status: New
• Public Device Record Key: 1a7a7a9e-06c3-4280-b07b-4715e6147d3b

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
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	862.1695	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54413	Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of free thyroxine (FT4) in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06947145577971	GS1

Premarket Submissions

Submission Number	Supplement Number
K182423	000

Storage Conditions

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