Wondfo
20-Strip HCG Pregnancy Tests, 50-Strip LH-Ovulation Test, and 70 Plastic Urine Cups
30manufacturers in China registered for this device type
16catalogue 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 | Wondfo USA Co., Ltd., 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, Complaint-file establishment, Manufacturer |
| 510(k) | K043443 |
| Record published | 2023-08-02 |
| Record revised | 2024-10-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 30 °C |
| Packaging | Pack of 120, pack of 20, pack of 60, pack of 50, pack of 100, pack of 16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DW1-S | 50 | In distribution | |
| DW1-S10-25BX-B | 25 | In distribution | |
| SW1-C | 100 | In distribution | |
| WS-H20L50-CA | 70 | In distribution | |
| WS-H10L25 | 35 | In distribution | |
| WS-H10L40 | 50 | In distribution | |
| W1-M | 25 | In distribution | |
| DW1-M | 25 | In distribution | |
| W1-S3 | 100 | In distribution | |
| WS-H5L20 | 25 | In distribution | |
| WS-H10L25-CA | 35 | In distribution | |
| W1-S25-AC | 25 | In distribution | |
| DW1-S10-25BX-CA | 25 | In distribution | |
| DW1-M-DW | In distribution | ||
| SW1-S | 100 | In distribution | |
| W1-M4 | 25 | 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 |
| 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 |
| 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.