Atida hCG Pregnancy Rapid Combo Test

GUDID 80810164510101

25T, FDA OTC

ACESO LABORATORIES INC.

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

• Primary Device ID: 80810164510101
• NIH Device Record Key: d1cf0f59-4ac3-46d2-83d3-f0b3e5bd45d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atida hCG Pregnancy Rapid Combo Test
• Version Model Number: US02-HCG-US
• Company DUNS: 003099455
• Company Name: ACESO LABORATORIES INC.
• Device Count: 25
• 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	00810164510105 [Primary]
GS1	80810164510101 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203272

FDA Product Code

• JHI: Visual, Pregnancy Hcg, Prescription Use

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

Devices Manufactured by ACESO LABORATORIES INC.

• 00810164510006 - ACESO Early Pregnancy Test: 2026-03-31 1T, FDA OTC
• 80810164510019 - ACESO Early Pregnancy Test: 2026-03-31 2T, FDA OTC
• 80810164510026 - ACESO Early Pregnancy Test: 2026-03-31 5T, FDA OTC
• 80810164510033 - ACESO Early Pregnancy Test: 2026-03-31 10T, FDA OTC
• 80810164510040 - ACESO Early Pregnancy Test: 2026-03-31 15T, FDA OTC
• 80810164510057 - ACESO Early Pregnancy Test: 2026-03-31 20T, FDA OTC
• 80810164510064 - ACESO Early Pregnancy Test: 2026-03-31 25T, FDA OTC
• 80810164510071 - Atida Fentanyl Drug of Abuse Test Rx: 2026-03-31 25T, FDA