SUPER-AID

GUDID 06923304600025

Weihai Kangzhou Biotechnology Engineering Co., Ltd

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 06923304600025
• NIH Device Record Key: b2749592-bfab-494d-85c2-cabba1c1b96a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPER-AID
• Version Model Number: midstream
• Company DUNS: 560448061
• Company Name: Weihai Kangzhou Biotechnology Engineering 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	06923304600025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183097

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

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: 2023-08-22
• Device Publish Date: 2023-08-14

On-Brand Devices [SUPER-AID]

• 06923304621129: Cassette
• 06923304600025: midstream