MAGLUMI 2000 HCG/beta-HCG

Basic Information

• Brand Name: MAGLUMI 2000 HCG/beta-HCG
• Primary DI: 06947145578046
• Version / Model: 130202022M
• Catalog Number: 130202022M
• 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: 2024-05-11
• Public Version: 1
• Public Version Date: 2024-05-20
• Public Version Status: New
• Public Device Record Key: 117000f2-cfce-4da4-80fe-ac85b938b015

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
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38262	Total human chorionic gonadotropin IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06947145578046	GS1

Premarket Submissions

Submission Number	Supplement Number
K192547	000

Storage Conditions

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