Cedia Opiate OFT Assay
Cedia Opiate OFT Assay qualitatively detects opiates in human oral fluid at a cutoff of 30 ng/mL in neat fluid. It is calibrated against morphine and performed on the MGC240 in a clinical…
Cedia Opiate OFT Assay qualitatively detects opiates in human oral fluid at a cutoff of 30 ng/mL in neat fluid. It is calibrated against morphine and performed on the MGC240 in a clinical laboratory using samples collected exclusively with Oral-Eze.
The homogeneous enzyme immunoassay uses two inactive beta-galactosidase fragments. Sample analyte competes for antibody binding, allowing active enzyme to form and produce a measurable color change proportional to analyte.
Confirmation
The result is preliminary. Confirmation requires a more specific method, with gas chromatography-mass spectrometry or liquid chromatography-tandem mass spectrometry preferred, and positive findings require clinical and professional interpretation.
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 | Microgenics Corporation, United States |
|---|---|
| FDA product code | DJG |
| Device type | Enzyme Immunoassay, Opiates |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3650 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K101754 |
| Record published | 2016-09-22 |
| Record revised | 2018-07-06 (version 3) |
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 |
|---|---|---|
| 10018600 | In distribution | |
| 10021778 | In distribution | |
| 10014873 | 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 |
|---|---|
| K231007 | 2023-09-27 |
| K192943 | 2019-12-16 |
| K173195 | 2018-02-13 |
| K173183 | 2017-11-22 |
| K163101 | 2017-04-06 |
| K150502 | 2015-10-09 |
| K101754 | 2011-04-08 |
| K040316 | 2004-06-23 |
| K011150 | 2001-06-20 |
| K001178 | 2000-06-09 |
| K945343 | 1995-01-17 |
| K941195 | 1994-09-07 |
| K935346 | 1994-01-11 |
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.