Aceso Early Pregnancy Test
Aceso Early Pregnancy Test is a urine test for the qualitative detection of human chorionic gonadotropin, or hCG, as an aid to detecting pregnancy. A test strip sits inside a plastic…
Aceso Early Pregnancy Test is a urine test for the qualitative detection of human chorionic gonadotropin, or hCG, as an aid to detecting pregnancy. A test strip sits inside a plastic housing with an absorbent tip for dip or midstream sampling.
Urine moves through the strip by capillary action and mixes with antibody-dye particles. If hCG is present, the resulting complexes bind at a second antibody line, producing a red test band.
Listed Item
20T, FDA OTC
Test and Control Lines
A control band develops separately to indicate that fluid has passed through the test system. The result is read as a visual positive or negative pattern within the specified 3- to 10-minute result window. The ready-to-use test is intended for home use.
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (5), Shanghai (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Core Technology Co., Ltd. | Changping District | Beijing | Contract manufacturer | 14 |
| Abbott Diagnostics (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
Showing 12 of 30. All 30 manufacturers in China registered for Kit, Test, Pregnancy, Hcg, Over The Counter
Record
| Listed by | Aceso Laboratories Inc., United States |
|---|---|
| FDA product code | LCX |
| Device type | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1155 |
| Establishment | Manufacturer |
| 510(k) | K234152 |
| Record published | 2026-03-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| U03ST-UHCG-US | 20 | In distribution | |
| U03ST-UHCG-US | In distribution | ||
| U03ST-UHCG-US | 5 | In distribution | |
| U03ST-UHCG-US | 2 | In distribution | |
| U03ST-UHCG-US | 15 | In distribution | |
| U03ST-UHCG-US | 25 | In distribution | |
| U03ST-UHCG-US | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CVS Health | Woonsocket Prescription Center, Incorporated | 55 |
| Walgreens | Walgreen Co. | 37 |
| H.E.B | H. E. Butt Grocery Company | 26 |
| Clearblue | SPD Swiss Precision Diagnostics Gmbh | 23 |
| Amplim | Amplim, LLC | 20 |
| Up & Up | Target Health, Inc. | 17 |
| Wondfo | Wondfo USA Co., Ltd. | 16 |
| Equate | Wal Mart Stores, Inc | 14 |
| Meijer | Meijer, Inc. | 12 |
| Leader | Cardinal Health 110, Inc. | 10 |
| Rite Aid Pharmacy | SPD Swiss Precision Diagnostics Gmbh | 8 |
| VeriQuick | Fourstar Group | 8 |
Showing 12 of 327. All products under Kit, Test, Pregnancy, Hcg, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K234152 | 2024-04-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.