Healgen (Private Label) – 242
Healgen (DrugConfirm) - 4 panel Cup AMP1000/COC300/MET1000/OPI2000
16manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (8), Guangdong (4), Tianjin (1). 3 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 Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| 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 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
| Eterbio, Inc. | Zhuhai | Guangdong | Manufacturer | 29 |
| Safecare Biotech(Hangzhou)Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 22 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 16. All 16 manufacturers in China registered for Test, Amphetamine, Over The Counter
Record
| Listed by | Confirm Biosciences LLC, United States |
|---|---|
| FDA product code | NFT |
| Device type | Test, Amphetamine, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3100 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| Record published | 2019-10-09 |
| Record revised | 2022-12-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CB-HE-CUP-242 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover Plus | American Screening, L.L.C. | 59 |
| Precision DX | American Screening, L.L.C. | 42 |
| Discover | American Screening, L.L.C. | 32 |
| iScreen™ | Instant Technologies, Inc. | 31 |
| Reveal | American Screening, L.L.C. | 26 |
| Prime Screen | Wondfo USA Co., Ltd. | 20 |
| U-Catch | Shenzhen Bioeasy Biotechnology Co., Ltd. | 19 |
| SAFElife™ | Wondfo USA Co., Ltd. | 18 |
| DrugTect Multi-Drug Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 17 |
| Precision Plus | American Screening, L.L.C. | 12 |
| Rapid Response | Btnx Inc. | 11 |
| OneScreen | American Screening, L.L.C. | 9 |
Showing 12 of 113. All products under Test, Amphetamine, 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.