SURESIGN™ Early Detection Pregnancy Test + Digital Pregancy Rapid Test

GUDID 50045611010036

1ct 10mIU Early Detection Pregnancy Test +1ct 25mIU Digital Pregancy Rapid Test

Guangzhou Decheng Biotechnology Co., LTD

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

• Primary Device ID: 50045611010036
• NIH Device Record Key: f689ad22-bc24-4120-9390-92796911faca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURESIGN™ Early Detection Pregnancy Test + Digital Pregancy Rapid Test
• Version Model Number: 01003-1
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00045611010031 [Primary]
GS1	50045611010036 [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: 2026-02-05
• Device Publish Date: 2026-01-28

Devices Manufactured by Guangzhou Decheng Biotechnology Co., LTD

• 50045611010005 - SURESIGN™ Pregnancy Rapid Test: 2026-02-05 5ct 25mIU - Single Step Pregnancy Test
• 50045611010012 - SURESIGN™ Early Detection Pregnancy Test: 2026-02-05 5ct 10mIU - 6 Day Early Pregnancy Test
• 50045611010029 - SURESIGN™ Digital Pregnancy Rapid Test: 2026-02-05 3ct 25mIU - Digital Pregnancy Test
• 50045611010036 - SURESIGN™ Early Detection Pregnancy Test + Digital Pregancy Rapid Test: 2026-02-051ct 10mIU Early Detection Pregnancy Test +1ct 25mIU Digital Pregancy Rapid Test
• 50045611010036 - SURESIGN™ Early Detection Pregnancy Test + Digital Pregancy Rapid Test: 2026-02-05 1ct 10mIU Early Detection Pregnancy Test +1ct 25mIU Digital Pregancy Rapid Test
• 50045611010043 - SURESIGN™ Ovulation & Pregnancy Rapid Tests: 2026-02-05 10ct Ovulation Rapid Test Midstream + 1ct 25mIU Pregnancy Rapid Test
• 50045611010050 - SURESIGN™ Menopause (FSH) Rapid Test: 2026-02-05 2ct Menopause (FSH) Rapid Test
• 50045611010074 - SURESIGN™ Digital Ovulation Rapid Test: 2026-02-05 1ct Digital Ovulation Rapid Test Holder + 20ct Digital Ovulation Rapid Test Stick
• 30011822020283 - RITE AID: 2025-09-08 RITE AID Pregnancy Test Strips, 50T/Bag