Precision DX
38 catalogue numbers from PREDX-DOA134N, listed by American Screening, L.L.C., under Test, Opiates, Over The Counter. 18 manufacturers in China are registered for this product code.
18manufacturers in China registered for this device type
38catalogue numbers in this listing
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 | American Screening, L.L.C. |
|---|---|
| FDA product code | NGL |
| Device type | Test, Opiates, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3650 |
| 510(k) | K180349 |
| Record published | 2022-11-11 |
| Record revised | 2024-10-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PREDX-DOA134N | In distribution | |
| PREDX-CUP1144N | In distribution | |
| PREDX-CUP3124N | In distribution | |
| PREDXCUP2174BL | In distribution | |
| PREDX-CUP8174N | In distribution | |
| PREDX-CUP-374N | In distribution | |
| PREDXCUP3154N | In distribution | |
| PREDXCUP6174NS | In distribution | |
| PREDX-ADT-254 | In distribution | |
| PREDX-SAL-124 | In distribution | |
| PREDXOSAL254I | In distribution | |
| PREDX-ADT-164 | In distribution | |
| PREDX-DOA-284N | In distribution | |
| PREDX-MDCT-U12 | In distribution | |
| PREDXCUP30124N | In distribution | |
| PREDX-DOA5104N | In distribution | |
| PREDXCUP6174NS | In distribution | |
| PREDX-DOA2104N | In distribution | |
| PREDX-CUP-254N | In distribution | |
| PREDX-DOA2104N | In distribution | |
| PREDXCUP20124G | In distribution | |
| PREDX-DOA134N | In distribution | |
| PREDX-MDCT-U12 | In distribution | |
| PREDX-DOA1374N | In distribution | |
| PREDX-ADT-254 | In distribution | |
| PREDX-CUP-394N | In distribution | |
| PREDXCUP20124D | In distribution | |
| PREDX-AMP-114N | In distribution | |
| PREDX-CUP5134N | In distribution | |
| PREDX-BUP-114N | In distribution | |
| PREDX-DOA364NG | In distribution | |
| PREDX-CUP1146N | In distribution | |
| PREDX-DOA2124N | In distribution | |
| PREDXDOA2064NU | In distribution | |
| PREDXDOA6124NT | In distribution | |
| PREDX-CUP-164N | In distribution | |
| PREDX-DOA2135N | In distribution | |
| PREDX-CUP7144N | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover | American Screening, L.L.C. | 40 |
| 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 |
| Clungene | Hangzhou Clongene Biotech Co., Ltd. | 4 |
Showing 12 of 90. All products under Test, Opiates, 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.