Detector hCG Stick
4 catalogue numbers from IHS-25OR, listed by Immunostics, Inc., United States, under Visual, Pregnancy Hcg, Prescription Use. 16 manufacturers in China are registered for this product code.
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 | Immunostics, Inc., United States |
|---|---|
| FDA product code | JHI |
| Device type | Visual, Pregnancy Hcg, Prescription Use |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1155 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2025-03-31 (version 6) |
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 |
| Storage | Storage environment temperature 4 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IHS-25OR | 25 | In distribution | |
| IHS-100 | 100 | In distribution | |
| IHS-50 | 50 | In distribution | |
| IHS-25 | 25 | 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 |
| QuickVue | Quidel Corp. | 5 |
| Medline | Medline Industries, Inc. | 5 |
Showing 12 of 113. All products under Visual, Pregnancy Hcg, Prescription Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K041728 | 2004-08-11 |
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.