ToxCup Drug Screen Cup
AMP1000/COC300/MET500/OPI2000/PCP25/THC50 Adulteration Screen for CR/NI/PH/BL/SG
18manufacturers in China registered for this device type
13catalogue numbers in this listing
3510(k) clearances naming 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 | Branan Medical Corporation, United States |
|---|---|
| FDA product code | LDJ |
| Device type | Enzyme Immunoassay, Cannabinoids |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3870 |
| 510(k) | K032057 |
| Record published | 2016-08-01 |
| Record revised | 2022-06-10 (version 6) |
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 15 to 30 °C; Handling environment temperature 15 to 30 °C |
| Distribution end date | 2020-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PT27A | Withdrawn | |
| PT30 | Withdrawn | |
| PT05A | Withdrawn | |
| PT15 | Withdrawn | |
| PT15A | Withdrawn | |
| PT08 | Withdrawn | |
| PT29A | Withdrawn | |
| PT12 | Withdrawn | |
| PT11A | Withdrawn | |
| PT11 | Withdrawn | |
| PT12A | Withdrawn | |
| PT24 | Withdrawn | |
| PT13 | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122633 | 2013-02-07 |
| K012541 | 2001-09-04 |
| K002263 | 2000-11-27 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ameditech, Inc. | 510(k) number | 2020-08-18 | Class II | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. | 189,175 units | 2024-09-30 |
| Branan Medical Corporation | 510(k) number | 2014-03-26 | Class II | Labeling Change Control | May be labeled with incorrect result interpretation graphics on the ToxCup lid label. | 9,800 units | 2014-07-23 |
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.