Hy-Vee® 6 Days Sooner/Early Detection Pregnancy Test

GUDID 00075450847659

HyVee Pregnancy Test Early 1 CT

Guangzhou Decheng Biotechnology Co., LTD

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

• Primary Device ID: 00075450847659
• NIH Device Record Key: 2d619465-deea-4583-b8d6-8514215901d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hy-Vee® 6 Days Sooner/Early Detection Pregnancy Test
• Version Model Number: IT415-1/V407
• Company DUNS: 554534314
• Company Name: Guangzhou Decheng Biotechnology 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: 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	00075450847659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240643

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: 2026-03-02
• Device Publish Date: 2026-02-20

On-Brand Devices [Hy-Vee® 6 Days Sooner/Early Detection Pregnancy Test]

• 00075450847659: HyVee Pregnancy Test Early 1 CT
• 00075450847642: HyVee Pregnancy Test Early 2CT
• 30075450847636: HyVee Pregnancy Test Early 3CT