McKesson
Test KIT, Preg HCG Cassette WA
16manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), Guangdong (3), Beijing (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| 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 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Taizhou Chenguang Import AND Export Trading Co., Ltd. | Taizhou | Jiangsu | Exporter | 25 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
| Anhui Deepblue Medical Technology Co., Ltd. | Hefei | Anhui | Contract manufacturer | 16 |
| Hangzhou Aichek Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 13 |
Showing 12 of 16. All 16 manufacturers in China registered for Visual, Pregnancy Hcg, Prescription Use
Record
| Listed by | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | JHI |
| Device type | Visual, Pregnancy Hcg, Prescription Use |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1155 |
| Record published | 2025-08-14 |
| Record revised | 2023-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 35135 | 35 | In distribution | |
| 181-35125 | 25 | In distribution | |
| 181-35025 | 25 | In distribution | |
| 5001 | 25 | In distribution | |
| 35035 | 35 | In distribution | |
| 5002 | 25 | In distribution | |
| 5000 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| Rapid Response | Btnx Inc. | 7 |
| Visual, Pregnancy Hcg, Prescription Use | W.h.p.m., Inc. | 6 |
| Preview | Wondfo USA Co., Ltd. | 6 |
| Sure-Vue | Fisher Scientific Company L.L.C. | 6 |
| Wondfo | Wondfo USA Co., Ltd. | 6 |
| Aimstep Pregnancy | Germaine Laboratories, Inc. | 5 |
| AlereTM | Alere San Diego, Inc. | 5 |
| Detector hCG | Immunostics, Inc. | 5 |
| QuickVue | Quidel Corp. | 5 |
| Medline | Medline Industries, Inc. | 5 |
| Henry Schein | Henry Schein, Inc. | 4 |
Showing 12 of 113. All products under Visual, Pregnancy Hcg, Prescription Use
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | a. 108 b. 838 c. 1225 |
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.