Verdict®-II
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, and Methamphetamine (MAMP),…
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, and Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) drugs and/or their metabolites in human urine.
Who Else Makes It
Concentrated in Zhejiang (8), Beijing (2), Guangdong (2). 6 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 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| 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 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Hangzhou Clongene Biotech Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 21 |
| Hangzhou Laihe Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 10 |
Record
| Listed by | Medtox Diagnostics, Inc., United States |
|---|---|
| FDA product code | DJC |
| Device type | Thin Layer Chromatography, Methamphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3610 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K010226 |
| Record published | 2016-09-16 |
| Record revised | 2022-06-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 25 °C |
| Packaging | Kit box of 25 |
| Distribution end date | 2021-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 601640 | Withdrawn | |
| 601598 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Advin Multi-Drug Screen Test | Advin Biotech, Inc. | 14 |
| First Sign® | Hemosure Inc. | 10 |
| Rapid Response | Btnx Inc. | 6 |
| Fastect II Drug Screen Dipstick Test | Branan Medical Corporation | 6 |
| Identify Health | Medical Distribution Group Inc | 5 |
| ProScreen | Instant Tech Subsidiary Acquisition | 5 |
| UCP Home Drug Screening Test Cards | UCP Biosciences, Inc. | 5 |
| Thin Layer Chromatography, Methamphetamine | Chemtron Biotech, Inc. | 3 |
| QuickProfile™ Drugs of Abuse Panel 7 Test | Lumiquick Diagnostics, Inc. | 3 |
| SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup | Alere San Diego, Inc. | 3 |
| Identify Diagnostics USA | Medical Distribution Group Inc | 3 |
| ImmuTest Drugs of Abuse Screen Card | Ameditech, Inc. | 3 |
Showing 12 of 87. All products under Thin Layer Chromatography, Methamphetamine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K022141 | 2002-07-30 |
| K010226 | 2001-06-01 |
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.