MGC HEALTH

GUDID 00383173000450

MGC HEALTH™ DIGITAL PREGNANCY RAPID TEST, 2T/Box

Guangzhou Decheng Biotechnology Co., LTD

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

• Primary Device ID: 00383173000450
• NIH Device Record Key: 8db60e76-6e13-42c1-a525-4c8b39c589f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGC HEALTH
• Version Model Number: 2T
• Company DUNS: 554534314
• Company Name: Guangzhou Decheng Biotechnology Co., LTD
• Device Count: 2
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383173000450 [Primary]
GS1	30383173000451 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222305

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: 2024-10-07
• Device Publish Date: 2024-09-27

On-Brand Devices [MGC HEALTH]

• 30383173000598: MGC HEALTH™ OVULATION RAPID TEST, 20T/Box
• 30383173000581: MGC HEALTH™ ANALOG PREGNANCY RAPID TEST, 2T/Box
• 00383173000573: MGC HEALTH™ ANALOG PREGNANCY RAPID TEST, 1T/Box
• 00383173000450: MGC HEALTH™ DIGITAL PREGNANCY RAPID TEST, 2T/Box
• 30383173000260: MGC HEALTH™ D-PEN™ MINI COC ORAL FLUID TEST, 2T/Box
• 30383173000253: MGC HEALTH™ D-PEN™ MINI THC ORAL FLUID TEST, 2T/Box
• 00383173000221: MGC HEALTH™ D-PEN™ ORAL FLUID DRUG TEST, 6-Panel, 1T/Box