Lumipulse G BHCG Immunoreaction Cartridges

Basic Information

• Brand Name: Lumipulse G BHCG Immunoreaction Cartridges
• Primary DI: 04987270235232
• Version / Model: 235232
• Company Name: FUJIREBIO INC.
• Labeler DUNS: 710873907
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-01
• Public Version: 5
• Public Version Date: 2023-02-09
• Public Version Status: Update
• Public Device Record Key: c7baa418-f386-489e-baf8-4abb1e7fc6d4

Device Characteristics

• Single Use: No
• 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
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42664	Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human chorionic gonadotropin beta-core fragment, a metabolite of human chorionic gonadotropin beta-subunit (beta-HCG), 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	04987270235232	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Right side up with care; no vibration
• Type: Storage Environment Temperature
• Temperature Range: 2 – 10 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 2 – 10 Degrees Celsius