LZI Methadone II Enzyme Immunoassay
The LZI Methadone II Enzyme Immunoassay screens human urine for methadone at a cutoff of 300 ng/mL. It provides qualitative or semiquantitative results for prescription use on automated…
The LZI Methadone II Enzyme Immunoassay screens human urine for methadone at a cutoff of 300 ng/mL. It provides qualitative or semiquantitative results for prescription use on automated clinical chemistry analysers.
The ready-to-use kit contains antibody and substrate reagent and a separate enzyme-labelled methadone conjugate. Methadone in the sample competes for antibody binding, leaving enzyme activity that produces an absorbance change measured at 340 nm.
Listed Item
Large Test Kit Antibody/Substrate Reagent (R1): 1000 mL Enzyme Conjugate Reagent (R2): 375 mL
Preliminary Testing
The assay result requires confirmation by a more specific analytical chemistry method. Semiquantitative results support specimen dilution for confirmatory testing or laboratory quality control rather than a final confirmed result.
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (2), Beijing (1). 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 |
| 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 |
| 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 |
| Hongkong Conlight Medical Group Limited | Tai Kok Tsui | Hong Kong | Specification developer | 11 |
Record
| Listed by | LIN-ZHI International, Inc., United States |
|---|---|
| FDA product code | DJR |
| Device type | Enzyme Immunoassay, Methadone |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3620 |
| Establishment | Manufacturer |
| 510(k) | K192433 |
| Record published | 2021-05-03 |
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 |
|---|---|---|
| 0631 | In distribution | |
| 0630 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Healgen | Healgen Scientific Limited Liability Company | 56 |
| Identify Diagnostics Drug Test Cups | Medical Distribution Group Inc | 23 |
| DOA 5 Panel Test | Rapid Diagnostics, Inc. | 20 |
| Advin Multi-Drug Screen Test | Advin Biotech, Inc. | 14 |
| ProScreen | Instant Tech Subsidiary Acquisition | 13 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 12 |
| UCP Compact Drug Test Cups | UCP Biosciences, Inc. | 12 |
| MD DugScreen | Medical Disposables Corp | 12 |
| CLIAwaived | Cliawaived,inc. | 11 |
| QuickTox Drug Screen Dipcard | Branan Medical Corporation | 10 |
| U-Screen | Instant Tech Subsidiary Acquisition | 7 |
| First Sign® | Hemosure Inc. | 7 |
Showing 12 of 170. All products under Enzyme Immunoassay, Methadone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192433 | 2019-10-04 |
| K170416 | 2017-06-26 |
| K051058 | 2006-03-29 |
| K031797 | 2003-10-10 |
| K023317 | 2002-12-12 |
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.