ARK™ Eddp Assay – 500ml
The ARK EDDP Assay is a prescription laboratory test for detecting EDDP in human urine with an automated clinical chemistry analyzer. It provides qualitative or semiquantitative results…
The ARK EDDP Assay is a prescription laboratory test for detecting EDDP in human urine with an automated clinical chemistry analyzer. It provides qualitative or semiquantitative results using cutoff concentrations of 100 or 300 ng/ml. Results are preliminary screening findings that require a more specific chemical method to confirm a positive result.
EDDP in the sample competes with an enzyme-labeled EDDP derivative for antibody binding sites. This changes enzyme activity in proportion to the sample’s EDDP concentration. The active enzyme produces NADH, creating an absorbance change that the analyzer measures with light.
Listed Item
The ARK™ EDDP Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of EDDP in human urine at cutoff concentrations of 100ng/mL and 300ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting EDDP in urine on automated clinical chemistry analyzers.
Reagents
The assay uses two liquid, ready-to-use reagents. R1 contains anti-EDDP rabbit antibody and substrate; R2 contains an EDDP derivative labeled with recombinant glucose-6-phosphate dehydrogenase. Reagents are stored at 2 to 8 degrees Celsius until their expiration date.
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 | ARK Diagnostics Inc, United States |
|---|---|
| FDA product code | DJR |
| Device type | Enzyme Immunoassay, Methadone |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3620 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K182779 |
| Record published | 2019-01-21 |
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 |
|---|---|---|
| 5051-0001-02 | In distribution |
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Showing 12 of 170. All products under Enzyme Immunoassay, Methadone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182779 | 2018-11-21 |
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.