AlereTM Tox Screen
Catalogue number KC840A, listed by Instant Technologies, Inc., under Enzyme Immunoassay, Cannabinoids. 18 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (4), Beijing (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 |
| 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 18. All 18 manufacturers in China registered for Enzyme Immunoassay, Cannabinoids
Record
| Listed by | Instant Technologies, Inc. |
|---|---|
| FDA product code | LDJ |
| Device type | Enzyme Immunoassay, Cannabinoids |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3870 |
| Record published | 2016-09-24 |
| Record revised | 2022-06-10 (version 5) |
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 |
|---|---|---|---|
| KC840A | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DrugCheck | Express Diagnostics Int’l., Inc. | 378 |
| Advin Multi-Drug Screen Test | Advin Biotech, Inc. | 234 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 167 |
| T-Cup | Wondfo USA Co., Ltd. | 63 |
| Wondfo Drug Test Dip Card | Wondfo USA Co., Ltd. | 56 |
| Enzyme Immunoassay, Cannabinoids | Alere San Diego, Inc. | 48 |
| Premier Bio-Cup & Bio-Dip | Premier Biotech, LLC | 46 |
| Enzyme Immunoassay, Cannabinoids | W.h.p.m., Inc. | 35 |
| MD DugScreen | Medical Disposables Corp | 24 |
| AllSource Screening Solutions – Drug Detector | Allsource Screening Solutions | 18 |
| Preview | Wondfo USA Co., Ltd. | 18 |
| Identify Diagnostics Drug Test Cups | Medical Distribution Group Inc | 17 |
Showing 12 of 288. All products under Enzyme Immunoassay, Cannabinoids
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P950040 | 1997-01-21 | DR. BROWN’S HOME DRUG TESTING KIT | Personal Health & Hygiene, Inc. |
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.