Superbio Immunofluorescence Analyzer

Basic Information

• Brand Name: Superbio Immunofluorescence Analyzer
• Primary DI: 06974521002246
• Version / Model: EASY-11
• Catalog Number: SUPE01106
• Company Name: Shenzhen Superbio Technology Co., Ltd.
• Labeler DUNS: 724542368
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-22
• Public Version: 1
• Public Version Date: 2023-03-30
• Public Version Status: New
• Public Device Record Key: 6b97f724-4179-4d2c-9127-48c9fc8b433f

Device Characteristics

• Single Use: No
• 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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	862.2560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56705	Fluorescent immunoassay analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974521002246	GS1

Premarket Submissions

Submission Number	Supplement Number
K220046	000