Bioeasy Immunofluorescence Analyzer YRLE01106

GUDID 06974521006626

Shenzhen Superbio Technology Co., Ltd.

Fluorescent immunoassay analyser IVD, laboratory

• Primary Device ID: 06974521006626
• NIH Device Record Key: 3ef823fa-f40e-403c-a455-bda0c959b3db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioeasy Immunofluorescence Analyzer
• Version Model Number: EASY-11
• Catalog Number: YRLE01106
• Company DUNS: 724542368
• Company Name: Shenzhen Superbio Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974521006626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220046

FDA Product Code

• KHO: Fluorometer, For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-30
• Device Publish Date: 2023-03-22

Devices Manufactured by Shenzhen Superbio Technology Co., Ltd.

• 06974521002239 - S-Trust Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay): 2023-03-30
• 06974521002246 - Superbio Immunofluorescence Analyzer: 2023-03-30
• 06974521006619 - U-Catch Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay): 2023-03-30
• 06974521006626 - Bioeasy Immunofluorescence Analyzer: 2023-03-30
• 06974521006626 - Bioeasy Immunofluorescence Analyzer: 2023-03-30