U-Catch Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) YRLF065025

GUDID 06974521006619

Shenzhen Superbio Technology Co., Ltd.

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• Primary Device ID: 06974521006619
• NIH Device Record Key: 9b4cb99d-b6b5-4297-b288-f613ef808d60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U-Catch Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay)
• Version Model Number: 25 Tests/Kit
• Catalog Number: YRLF065025
• Company DUNS: 724542368
• Company Name: Shenzhen Superbio Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	06974521006619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220046

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

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