QuickVue
QkVue HCG Combo, 50T
16manufacturers in China registered for this device type
5catalogue numbers in this listing
20510(k) clearances naming this product code
1recall
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 | Quidel Corp., United States |
|---|---|
| FDA product code | JHI |
| Device type | Visual, Pregnancy Hcg, Prescription Use |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1155 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K020801 |
| Record published | 2016-09-15 |
| Record revised | 2025-12-08 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 12, case of 10, case of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| One-Step hCG Combo Test | In distribution | |
| One-Step hCG Urine Test | In distribution | |
| hCG S/U Test | In distribution | |
| hCG S/U Test | In distribution | |
| 20112 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| 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 |
| Medline | Medline Industries, Inc. | 5 |
| Henry Schein | Henry Schein, Inc. | 4 |
Showing 12 of 113. All products under Visual, Pregnancy Hcg, Prescription Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131166 | 2013-08-02 |
| K102175 | 2010-08-25 |
| K020801 | 2002-05-17 |
| K020799 | 2002-05-17 |
| K974052 | 1997-12-19 |
| K973841 | 1997-12-01 |
| K973858 | 1997-11-26 |
| K972748 | 1997-08-29 |
| K972742 | 1997-08-29 |
| K954273 | 1995-10-16 |
| K945969 | 1995-01-27 |
| K932042 | 1993-06-29 |
| K925435 | 1992-12-03 |
| K913122 | 1991-08-16 |
| K894790 | 1989-10-25 |
| K890615 | 1989-04-18 |
| K882086 | 1988-07-28 |
| K881595 | 1988-05-27 |
| K844082 | 1984-11-21 |
| K842692 | 1984-09-05 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Quidel Corp. | 510(k) number | 2010-11-23 | Not classified | Pending | The recall was initiated after Quidel Corporation determined that a small number of QuickVue One-Step hCG Urine kits have been incorrectly packaged with QuickVue H. pylori gll cassettes inside the kit boxes. These foil pouches and test cass | 3624 kits = 90,600 tests total | 2012-06-26 |
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.