Immunalysis
EDDP Specific Urine HEIA™
11manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
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 | Immunalysis Corporation, United States |
|---|---|
| FDA product code | DJR |
| Device type | Enzyme Immunoassay, Methadone |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3620 |
| 510(k) | K151395 |
| Record published | 2019-02-28 |
| Record revised | 2024-04-10 (version 6) |
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 |
|---|---|---|
| 04Z43-20 | In distribution | |
| 04W31-20 | In distribution | |
| 349UR-0500 | In distribution | |
| 349UR-0025 | In distribution | |
| 349UR-0060W | In distribution | |
| 349UR-0100 | 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 |
|---|---|
| K151395 | 2015-07-24 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Alere San Diego, Inc. | 510(k) number | 2017-11-28 | Class III | Under Investigation by firm | The High (125 ng/ml) Control does not meet specification – it has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry analyzers, which is below the 100 ng/mL cutoff of the EDDP Specific Urine Enzyme Imm | 37 kits | 2021-01-29 |
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.