SURESIGN™ Digital Ovulation Rapid Test

GUDID 50045611010074

1ct Digital Ovulation Rapid Test Holder + 20ct Digital Ovulation Rapid Test Stick

Guangzhou Decheng Biotechnology Co., LTD

Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing

• Primary Device ID: 50045611010074
• NIH Device Record Key: 1e48ad24-b22f-4396-b4ac-b56c98a89138
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURESIGN™ Digital Ovulation Rapid Test
• Version Model Number: 01007-9
• Company DUNS: 554534314
• Company Name: Guangzhou Decheng Biotechnology Co., LTD
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• 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	00045611010079 [Primary]
GS1	50045611010074 [Unit of Use]

FDA Product Code

• NGE: Test, Luteinizing Hormone (Lh), 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

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