HealthyMe Digital Pregnancy Test
Early Detection Digital Pregnancy Test
30manufacturers in China registered for this device type
3catalogue numbers in this listing
10510(k) clearances naming this product code
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 | Acon 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 | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2025-01-28 |
| Record revised | 2025-06-20 (version 2) |
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 |
| Storage | Storage environment temperature 36 to 86 °F |
| Packaging | Inner pack of 6, carton of 6 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| L031-20108-103 | 3 | In distribution | |
| L031-20108-101 | In distribution | ||
| L031-20108-102 | 2 | 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 |
|---|---|
| K232715 | 2024-05-31 |
| K193318 | 2020-08-20 |
| K050546 | 2005-05-20 |
| K042151 | 2004-09-09 |
| K033041 | 2003-11-21 |
| K032661 | 2003-10-14 |
| K032510 | 2003-09-22 |
| K012215 | 2001-08-07 |
| K993483 | 2000-01-20 |
| K983090 | 1998-11-18 |
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.