Premier Bio-Cup & Bio-Dip
AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/OPI300/OXY100/PCP25/THC50/(OX/pH/SG)
18manufacturers in China registered for this device type
46catalogue 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 | Premier Biotech, LLC, United States |
|---|---|
| FDA product code | LDJ |
| Device type | Enzyme Immunoassay, Cannabinoids |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3870 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-09-25 |
| Record revised | 2025-08-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PBCup-04-09 | 25 | In distribution | |
| PBCard-01-THC50 | 25 | In distribution | |
| PBCard-06-04 | 25 | In distribution | |
| PBCard-06-01 | 25 | In distribution | |
| PBCup-06-23 | 25 | In distribution | |
| PBCup-10-20 | 25 | In distribution | |
| PBCupA-10-32 | 25 | In distribution | |
| PBCupA-12-19 | 25 | In distribution | |
| PBCard-07-09 | 25 | In distribution | |
| PBCard-04-09 | 25 | In distribution | |
| PBCard-12-19 | 25 | In distribution | |
| PBCard-12-02 | 25 | In distribution | |
| PBCup-10-06 | 25 | In distribution | |
| PBCard-03-06 | 25 | In distribution | |
| PBCard-05-04 | 25 | In distribution | |
| PBCard-10-20 | 25 | In distribution | |
| PBCard-10-32 | 25 | In distribution | |
| PBCard-06-23 | 25 | In distribution | |
| PBCardA-12-19 | 25 | In distribution | |
| PBCardA-05-02 | 25 | In distribution | |
| PBCup-09-06 | 25 | In distribution | |
| PBCup-05-02 | 25 | In distribution | |
| PBCup-10-33 | 25 | In distribution | |
| PBCard-09-06 | 25 | In distribution | |
| PBCup-06-01 | 25 | In distribution | |
| PBCup-12-19 | 25 | In distribution | |
| PBCup-03-06 | 25 | In distribution | |
| PBCup-06-04 | 25 | In distribution | |
| PBCup-10-04 | 25 | In distribution | |
| PBCup-07-09 | 25 | In distribution | |
| PBCard-04-16 | 25 | In distribution | |
| PBCard-10-06 | 25 | In distribution | |
| PBCup-05-09 | 25 | In distribution | |
| PBCard-10-33 | 25 | In distribution | |
| PBCard-05-02 | 25 | In distribution | |
| PBCardA-10-32 | 25 | In distribution | |
| PBCard-05-09 | 25 | In distribution | |
| PBCard-04-17 | 25 | In distribution | |
| PBCup-12-02 | 25 | In distribution | |
| PBCup-05-04 | 25 | In distribution | |
| PBCard-10-04 | 25 | In distribution | |
| PBCard-M-10-20 | 25 | In distribution | |
| PBCupA-05-02 | 25 | In distribution | |
| PBCardA-09-06 | 25 | In distribution | |
| PBCup-10-32 | 25 | In distribution | |
| PBCupA-09-06 | 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 |
| 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
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.