Opiate Enzyme Immunoassay
The Opiate Enzyme Immunoassay detects opiates in human urine qualitatively or semiquantitatively at a 300 ng/mL cutoff. It is intended for professional laboratory use with compatible…
The Opiate Enzyme Immunoassay detects opiates in human urine qualitatively or semiquantitatively at a 300 ng/mL cutoff. It is intended for professional laboratory use with compatible automated clinical chemistry analyzers.
The ready to use liquid reagents use competition between specimen drug and morphine labeled enzyme for antibody binding. Enzyme activity changes with drug concentration, producing an absorbance change measured at 340 nm.
Confirmation and Controls
The assay produces a preliminary result that requires a more specific method for confirmation, preferably gas or liquid chromatography with mass spectrometry. Separate opiate calibrators establish assay calibration, and assayed controls monitor analytical precision.
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 | LIN-ZHI International, Inc., United States |
|---|---|
| FDA product code | DJG |
| Device type | Enzyme Immunoassay, Opiates |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3650 |
| Establishment | Manufacturer |
| 510(k) | K110298 |
| Record published | 2016-07-05 |
| Record revised | 2018-08-24 (version 4) |
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 |
|---|---|---|
| 0020b | In distribution | |
| 0021b | 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 |
| Immunalysis | Immunalysis Corporation | 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 |
Showing 12 of 316. All products under Enzyme Immunoassay, Opiates
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253082 | 2026-01-16 |
| K251634 | 2025-06-18 |
| K202007 | 2020-09-17 |
| K201938 | 2020-08-07 |
| K201223 | 2020-06-04 |
| K181159 | 2018-12-03 |
| K141205 | 2015-02-13 |
| K141055 | 2014-06-13 |
| K120763 | 2012-06-01 |
| K120761 | 2012-05-08 |
| K110298 | 2011-07-15 |
| K101195 | 2010-07-06 |
| K090844 | 2009-07-30 |
| K081008 | 2008-12-22 |
| K050733 | 2005-06-13 |
| K020368 | 2002-06-04 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-02-18 | Class III | Packaging | Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL). | 120 units, 60 of each lot number | 2014-04-25 |
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.