Alere Iscreen Dx
Urine Drug Screen Card for detection of Methamphetamine (MET) single drug, CLIA Waived
12manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Instant Technologies, Inc. |
|---|---|
| FDA product code | DJC |
| Device type | Thin Layer Chromatography, Methamphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3610 |
| 510(k) | K022355 |
| Record published | 2016-09-19 |
| Record revised | 2022-12-20 (version 7) |
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 59 to 86 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IS1 MET-DX | In distribution | |
| IS1 MDM-DX | In distribution |
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
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.