Tanner Scientific®
Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,Pregnancy Urine/Serum Combo 50BX
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 | Mercedes Medical LLC, 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 |
| 510(k) | K112101 |
| Record published | 2016-08-22 |
| Record revised | 2023-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 36 to 86 °F |
| Packaging | Inner pack of 50, case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TNR HCGCOMBO | 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
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 |
|---|---|---|---|---|---|---|---|
| Ekla Corporation | 510(k) number | 2016-10-20 | Class II | Process control | Incorrect hCG results | 295 kits | 2023-11-29 |
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.