Attest Drug Screen Dip Card
The Attest Drug Screen Dip Card 6AM10 screens human urine for 6-acetylmorphine at a cutoff of 10 ng/mL. It is a professional-use lateral-flow immunoassay providing a qualitative,…
The Attest Drug Screen Dip Card 6AM10 screens human urine for 6-acetylmorphine at a cutoff of 10 ng/mL. It is a professional-use lateral-flow immunoassay providing a qualitative, preliminary result rather than a measured drug concentration.
Urine travels along the test strip by capillary action, carrying labelled antibodies toward a fixed test region. Sample analyte competes with the immobilised drug conjugate for antibody binding, changing whether a visible test line forms.
Listed Item
6AM10
Line Interpretation
A visible test line indicates a negative result, while absence of that line indicates a preliminary positive. A separate control line must appear for the result to be interpreted; a missing control line requires a repeated test.
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 | Advin Biotech, Inc., 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, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K182123 |
| Record published | 2022-09-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1 | 25 | 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 |
|---|---|
| K201494 | 2020-09-17 |
| K182123 | 2019-03-29 |
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.