Methadone Metabolite Enzyme Immunoassay
5 catalogue numbers from 0191, listed by LIN-ZHI International, Inc., United States, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
5catalogue numbers in this listing
5510(k) clearances naming this product code
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) | K031797 |
| Record published | 2016-07-05 |
| Record revised | 2018-08-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| 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 |
|---|---|---|
| 0191 | In distribution | |
| 08735581190 | In distribution | |
| 09067671190 | In distribution | |
| 0191b | In distribution | |
| 0190b | 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.