Lumipulse G TSH-III Immunoreaction Cartridges

Basic Information

• Brand Name: Lumipulse G TSH-III Immunoreaction Cartridges
• Primary DI: 04987270235294
• Version / Model: 235294
• Company Name: FUJIREBIO INC.
• Labeler DUNS: 710873907
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-01
• Public Version: 3
• Public Version Date: 2023-01-13
• Public Version Status: Update
• Public Device Record Key: 4ec99a07-ebbd-443e-909c-e4bde12d070f
• Distribution End Date: 2023-01-12

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
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	862.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54386	Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) 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	04987270235294	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