BIOBASE

Basic Information

• Brand Name: BIOBASE
• Primary DI: 06971674865841
• Version / Model: R1:18mL×4 R2:6mL×4
• Company Name: Biobase Biodustry(Shandong)Co., Ltd.
• Labeler DUNS: 420046355
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-22
• Public Version: 1
• Public Version Date: 2023-07-31
• Public Version Status: New
• Public Device Record Key: 21a532f0-c6b7-4372-aeb7-27505d7f0692

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
JKZ	Diethyldithiocarbamate (Colorimetric), Copper	Clinical Chemistry	862.1190	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54748	Copper IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of copper (Cu) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971674865841	GS1