Immunalysis
6-Acetylmorphine Urine HEIA™
17manufacturers in China registered for this device type
37catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (4), Beijing (2). 5 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 |
| Prometheus Bio Inc. | Hangzhou | Zhejiang | Contract manufacturer | 12 |
| 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 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
Showing 12 of 17. All 17 manufacturers in China registered for Enzyme Immunoassay, Opiates
Record
| Listed by | Immunalysis Corporation, United States |
|---|---|
| FDA product code | DJG |
| Device type | Enzyme Immunoassay, Opiates |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3650 |
| 510(k) | K141803 |
| Record published | 2016-08-31 |
| Record revised | 2024-04-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 304UR-0500 | In distribution | |
| 302UR-0100 | In distribution | |
| 343UR-0025 | In distribution | |
| 347UR-0060W | In distribution | |
| 336UR-0100 | In distribution | |
| 618UR-0060W | In distribution | |
| 343UR-0500 | In distribution | |
| 347UR-0500 | In distribution | |
| 347UR-0100 | In distribution | |
| 343UR-0100 | In distribution | |
| 304UR-0100 | In distribution | |
| 04Z46-20 | In distribution | |
| 336UR-0500 | In distribution | |
| 618UR-0100 | In distribution | |
| 04Z42-20 | In distribution | |
| 618UR-0500 | In distribution | |
| 307UR-0025 | In distribution | |
| 302UR-0500 | In distribution | |
| 302UR-0025 | In distribution | |
| 347UR-0025 | In distribution | |
| 307UR-0060W | In distribution | |
| 302UR-0060W | In distribution | |
| 336UR-0060W | In distribution | |
| 307UR-0500 | In distribution | |
| 04W34-20 | In distribution | |
| 343UR-0060W | In distribution | |
| 04Z44-20 | In distribution | |
| 04W29-20 | In distribution | |
| 304UR-0060W | In distribution | |
| 04W32-20 | In distribution | |
| 04W30-20 | In distribution | |
| 618UR-0025 | In distribution | |
| 304UR-0025 | In distribution | |
| 04W33-20 | In distribution | |
| 04Z45-20 | In distribution | |
| 307UR-0100 | In distribution | |
| 336UR-0025 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Advin Multi-Drug Screen Test | Advin Biotech, Inc. | 75 |
| MD DugScreen | Medical Disposables Corp | 37 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 29 |
| DOA 6 Panel Test | Rapid Diagnostics, Inc. | 28 |
| First Sign® | Hemosure Inc. | 20 |
| Enzyme Immunoassay, Opiates | W.h.p.m., Inc. | 20 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 19 |
| MD DrugScreen | Medical Disposables Corp | 18 |
| DOA-7 Panel Test | Rapid Diagnostics, Inc. | 18 |
| DOA 5 Panel Test | Rapid Diagnostics, Inc. | 16 |
| Rapid Response | Btnx Inc. | 14 |
| DOA 4 Panel Test | Rapid Diagnostics, Inc. | 13 |
Showing 12 of 316. All products under Enzyme Immunoassay, Opiates
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252520 | 2025-09-11 |
| K203564 | 2021-12-22 |
| K161216 | 2017-06-14 |
| K143502 | 2015-05-20 |
| K150275 | 2015-03-09 |
| K141803 | 2015-02-12 |
| K141406 | 2014-07-01 |
| K131168 | 2014-01-17 |
| K051626 | 2005-10-13 |
| K913863 | 1991-09-19 |
| K871698 | 1987-06-15 |
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.