Winco Foods One Step Pregnancy Test

GUDID 00070552351134

One Step Pregnancy Test

WINCO FOODS, LLC

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

• Primary Device ID: 00070552351134
• NIH Device Record Key: 8c290c39-4ef1-423c-a6a0-59cfd136b0c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Winco Foods One Step Pregnancy Test
• Version Model Number: 25113
• Company DUNS: 056098817
• Company Name: WINCO FOODS, LLC
• 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: 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	00070552251137 [Primary]
GS1	00070552351134 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150022

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: 2026-02-17
• Device Publish Date: 2026-02-09

On-Brand Devices [Winco Foods One Step Pregnancy Test]

• 10070552250014: FPPL Winco Foods SPS +/-
• 00070552351134: One Step Pregnancy Test
• 00070552251120: One Step Pregnancy Test