BIOBASE

Basic Information

• Brand Name: BIOBASE
• Primary DI: 06971674863458
• Version / Model: R1:100mL×1 R2:25mL×1
• 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: 2023-07-21
• Public Version: 1
• Public Version Date: 2023-07-31
• Public Version Status: New
• Public Device Record Key: d834e937-e774-4c8d-95c8-d5f60842e759

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
JMK	Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase	Clinical Chemistry	862.1380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53058	Alpha-hydroxybutyrate dehydrogenase 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 quantitative measurement of alpha-hydroxybutyrate dehydrogenase in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971674863458	GS1