Equate
A convenience kit consisting of 1 Equate One Step Pregnancy Test, 1 Equate Early Result Pregnancy Test and 1 Equate Digital Yes+ No- Pregnancy Test
30manufacturers in China registered for this device type
14catalogue numbers in this listing
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 | Wal Mart Stores, Inc |
|---|---|
| FDA product code | LCX |
| Device type | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1155 |
| 510(k) | K210341 |
| Record published | 2023-03-16 |
| Record revised | 2023-07-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 30 °C |
| Packaging | Shipping case of 24, shipping case of 48 |
| Distribution end date | 2025-09-24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| One Step Pregnancy Test | In distribution | ||
| 677296456 | In distribution | ||
| Early Result Pregnancy Test | 2 | In distribution | |
| 677296455 | In distribution | ||
| Early Ovulation Kit | In distribution | ||
| 677296453 | In distribution | ||
| 677159574 | In distribution | ||
| Digital Pregnancy Test | 2 | In distribution | |
| 677296454 | In distribution | ||
| Triple Test Pregnancy Test Kit | Withdrawn | ||
| One Step Pregnancy Test | Withdrawn | ||
| One Step Pregnancy Test | 2 | Withdrawn | |
| Early Result Pregnancy Test | Withdrawn | ||
| One Step Pregnancy Test | 2 | Withdrawn |
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 |
| Meijer | Meijer, Inc. | 12 |
| Leader | Cardinal Health 110, Inc. | 10 |
| Rite Aid Pharmacy | SPD Swiss Precision Diagnostics Gmbh | 8 |
| VeriQuick | Fourstar Group | 8 |
| HORMONElife™ | Wondfo USA Co., Ltd. | 8 |
Showing 12 of 327. All products under Kit, Test, Pregnancy, Hcg, Over The Counter
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.