ACESO Early Pregnancy Test

GUDID 80810164510057

20T, FDA OTC

ACESO LABORATORIES INC.

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

• Primary Device ID: 80810164510057
• NIH Device Record Key: 6eed85ba-7a1e-41cf-9b56-8a2795d9cf4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACESO Early Pregnancy Test
• Version Model Number: U03ST-UHCG-US
• Company DUNS: 003099455
• Company Name: ACESO LABORATORIES INC.
• Device Count: 20
• 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	00810164510051 [Primary]
GS1	80810164510057 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234152

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: 2026-03-31
• Device Publish Date: 2026-03-23

On-Brand Devices [ACESO Early Pregnancy Test]

• 80810164510064: 25T, FDA OTC
• 80810164510057: 20T, FDA OTC
• 80810164510040: 15T, FDA OTC
• 80810164510033: 10T, FDA OTC
• 80810164510026: 5T, FDA OTC
• 80810164510019: 2T, FDA OTC
• 00810164510006: 1T, FDA OTC