| Primary Device ID | 00810164510709 |
| NIH Device Record Key | e6e3e13e-40ec-452d-a4a3-2a307964ffd6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Atida DIGITAL EARLY PREGNANCY TEST |
| Version Model Number | EKA02ST-HCG-US |
| Company DUNS | 003099455 |
| Company Name | ACESO LABORATORIES INC. |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00810164510709 [Primary] |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-31 |
| Device Publish Date | 2026-03-23 |
| 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 |