Co-Innovation
Catalogue number FYL TEST, listed by Co-Innovation Biotech Co., Ltd., China, under Test, Opiates, Over The Counter. 18 manufacturers in China are registered for this product code.
18manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (4), Beijing (2). 4 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 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Core Technology Co., Ltd. | Changping District | Beijing | Contract manufacturer | 14 |
| 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 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Eterbio, Inc. | Zhuhai | Guangdong | Manufacturer | 29 |
Showing 12 of 18. All 18 manufacturers in China registered for Test, Opiates, Over The Counter
Record
| Listed by | Co-Innovation Biotech Co., Ltd., China |
|---|---|
| FDA product code | NGL |
| Device type | Test, Opiates, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3650 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K241100 |
| Record published | 2024-08-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10, pack of 20, pack of 25, pack of 100 |
| Distribution end date | 2024-08-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FYL TEST | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover | American Screening, L.L.C. | 40 |
| Precision DX | American Screening, L.L.C. | 38 |
| Discover Plus | American Screening, L.L.C. | 22 |
| Precision Plus | American Screening, L.L.C. | 17 |
| OneScreen | American Screening, L.L.C. | 14 |
| Reveal | American Screening, L.L.C. | 11 |
| SAFElife™ | Wondfo USA Co., Ltd. | 11 |
| Rapid Response | Btnx Inc. | 8 |
| Identify Diagnostics Multi-Drug Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 6 |
| Amazewell | Guangzhou Decheng Biotechnology Co., Ltd. | 5 |
| Alltest | Hangzhou AllTest Biotech Co., Ltd. | 5 |
| UScreen | Guangzhou Decheng Biotechnology Co., Ltd. | 5 |
Showing 12 of 90. All products under Test, Opiates, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241100 | 2024-05-22 |
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.