T-Cup
13-Panel T-Cup; AMP500,BAR,BUP,BZO,COC150,mAMP500,MDMA,MOP,MTD,OXY,PCP,TCA,THC with 3AD
18manufacturers in China registered for this device type
63catalogue numbers in this listing
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 | Wondfo USA Co., Ltd., United States |
|---|---|
| FDA product code | LDJ |
| Device type | Enzyme Immunoassay, Cannabinoids |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3870 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K133968 |
| Record published | 2016-12-13 |
| Record revised | 2024-10-14 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 30 °C |
| Packaging | Pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TDOA-3135A3 | 25 | In distribution | |
| TDOA-7104 | In distribution | ||
| TDOA-6125V | 25 | In distribution | |
| TDOA-654A3 | 25 | In distribution | |
| TDOA-6124A3 | In distribution | ||
| TDOA-254A3 | In distribution | ||
| TDOA-6124 | In distribution | ||
| TDOA-6125A3V | 25 | In distribution | |
| TDOA-254 | 25 | In distribution | |
| TDOA-1144 | 25 | In distribution | |
| TDOA-2135 | In distribution | ||
| TDOA-654 | In distribution | ||
| TDOA-654A3 | In distribution | ||
| TDOA-4124 | 25 | In distribution | |
| TDOA-955 | 25 | In distribution | |
| TDOA-254A3 | 25 | In distribution | |
| TDOA-274 | 25 | In distribution | |
| TDOA-1144 | In distribution | ||
| TDOA-3124 | 25 | In distribution | |
| TDOA-264A3 | In distribution | ||
| TDOA-8104 | In distribution | ||
| TDOA-3104 | In distribution | ||
| TDOA-164 | 25 | In distribution | |
| TDOA-7104A3 | In distribution | ||
| TDOA-564 | 25 | In distribution | |
| TDOA-4104 | 25 | In distribution | |
| TDOA-7125 | In distribution | ||
| TDOA-2135 | 25 | In distribution | |
| TDOA-264 | In distribution | ||
| TDOA-1145A3 | 25 | In distribution | |
| TDOA-4124 | In distribution | ||
| TDOA-164 | In distribution | ||
| TDOA-2135A3 | In distribution | ||
| TDOA-3135 | 25 | In distribution | |
| TDOA-3104A3 | 25 | In distribution | |
| TDOA-6125A3 | In distribution | ||
| TDOA-1145A3 | In distribution | ||
| TDOA-7125 | 25 | In distribution | |
| TDOA-2135A3 | 25 | In distribution | |
| TDOA-264A3 | 25 | In distribution | |
| TDOA-1144A3 | 25 | In distribution | |
| TDOA-3104 | 25 | In distribution | |
| TDOA-7125A3 | In distribution | ||
| TDOA-154 | In distribution | ||
| TDOA-564 | In distribution | ||
| TDOA-264 | 25 | In distribution | |
| TDOA-4104 | In distribution | ||
| TDOA-6125 | 25 | In distribution | |
| TDOA-274 | In distribution | ||
| TDOA-6125A3 | 25 | In distribution | |
| TDOA-7104 | 25 | In distribution | |
| TDOA-3104A3 | In distribution | ||
| TDOA-254 | In distribution | ||
| TDOA-6124 | 25 | In distribution | |
| TDOA-3124 | In distribution | ||
| TDOA-6125 | In distribution | ||
| TDOA-654 | 25 | In distribution | |
| TDOA-6125V | In distribution | ||
| TDOA-6124A3 | 25 | In distribution | |
| TDOA-8104 | 25 | In distribution | |
| TDOA-4105A3 | 25 | In distribution | |
| TDOA-7125A3 | 25 | In distribution | |
| TDOA-154 | 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 |
| 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 |
| ImmuTest Drugs of abuse Cup | Ameditech, Inc. | 17 |
Showing 12 of 288. All products under Enzyme Immunoassay, Cannabinoids
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | 510(k) number | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | a. unk b. 6 c. 1 d. 1 e. 67 f. 1 g. 10 h. 51 i. 27 j. 105 k. |
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.