Lumipulse G Substrate Solution

Basic Information

• Brand Name: Lumipulse G Substrate Solution
• Primary DI: 04987270231197
• Version / Model: 231197
• Company Name: FUJIREBIO INC.
• Labeler DUNS: 710873907
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 5
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 29d4cbf0-45e1-4175-be6d-8d1999efd1bc

Device Characteristics

• Single Use: No
• 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
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	862.2160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58347	Chemiluminescent substrate reagent IVD	A substance or reactant that produces a luminescent signal in response to a biochemical reaction (e.g., luminol) and intended to be used in combination with other IVDs to test a clinical specimen, typically using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987270231197	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K142895	000

Device Sizes

Type	Value	Unit	Text
Total Volume	600	Milliliter

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