Lumipulse G CA 15-3 Calibrators

Basic Information

• Brand Name: Lumipulse G CA 15-3 Calibrators
• Primary DI: 04987270230640
• Version / Model: 230640
• Company Name: FUJIREBIO INC.
• Labeler DUNS: 710873907
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-12
• Public Version: 7
• Public Version Date: 2023-01-24
• Public Version Status: Update
• Public Device Record Key: 61ecaee5-850b-431a-b348-376d829def7e

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

GMDN Terms

Code	Name	Definition	Implantable	Status
38223	Cancer antigen 15-3 (CA15-3) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987270230640	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size Type = Units per kit; Units = 2; Unit of Measure = 3.0 mLs

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