Rapid Response
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/TCA) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates,…
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/TCA) – 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Tricyclic Antidepressant, Cocaine and THC metabolites in 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 | Btnx Inc., Canada |
|---|---|
| FDA product code | DJC |
| Device type | Thin Layer Chromatography, Methamphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3610 |
| Establishment | Repacker / relabeller, Private-label distributor, Complaint-file establishment, Exporter |
| 510(k) | K161044 |
| Record published | 2019-07-25 |
| Record revised | 2023-04-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MET-1S2-100 | 100 | In distribution | |
| D10.6-1P29-25 | 25 | In distribution | |
| MDM-1C9-40 | 40 | In distribution | |
| MET-1C2-40 | 40 | In distribution | |
| D5.1-1P29-25 | 25 | In distribution | |
| MDM-1S9-100 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Advin Multi-Drug Screen Test | Advin Biotech, Inc. | 14 |
| First Sign® | Hemosure Inc. | 10 |
| 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 |
| Instant-View Multi-Drugs of Abuse Urine Test AMP, COC, THC, XTC | Alfa Scientific Designs, Inc. | 3 |
Showing 12 of 87. All products under Thin Layer Chromatography, Methamphetamine
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.