DrugCheck
DrugCheck NxStep OnSite Drug Test CLIA Waived, AMP500-BARB-COC150-MET500-OPI-PCP-THC-pH,SG,OX-CR,NI
18manufacturers in China registered for this device type
167catalogue 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 | Express Diagnostic Int’l, Inc. |
|---|---|
| FDA product code | LDJ |
| Device type | Enzyme Immunoassay, Cannabinoids |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3870 |
| Record published | 2019-06-12 |
| Record revised | 2026-05-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 4 to 30 °C |
| Distribution end date | 2026-05-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 61058 | In distribution | |
| 30142C | In distribution | |
| 61051-3 BLK | In distribution | |
| 60925 | In distribution | |
| 50705-DC | In distribution | |
| 70600 | In distribution | |
| 61211 | In distribution | |
| 60711-5 | In distribution | |
| 60613-6 | In distribution | |
| 60526 | In distribution | |
| 60610 | In distribution | |
| 61307-5 | In distribution | |
| 31106-6 | In distribution | |
| 30554 | In distribution | |
| 30906 | In distribution | |
| 60629 | In distribution | |
| 65505-3 | In distribution | |
| 30713 | In distribution | |
| 50700-DC | In distribution | |
| 61032 | In distribution | |
| 31235 | In distribution | |
| 30140 | In distribution | |
| 30682 | In distribution | |
| 60505-3 | In distribution | |
| 60725-5 | In distribution | |
| 31135-5 | In distribution | |
| 30727 | In distribution | |
| 31103 | In distribution | |
| 61025-3 | In distribution | |
| 60600 | In distribution | |
| 30843 | In distribution | |
| 60821 | In distribution | |
| 60505 | In distribution | |
| 60710 | In distribution | |
| 60936 | In distribution | |
| 60831 | In distribution | |
| 65500-5 | In distribution | |
| 30902 | In distribution | |
| 30695 | In distribution | |
| 30960 | In distribution | |
| 31221 | In distribution | |
| 31215 | In distribution | |
| 30508 | In distribution | |
| 61121 | In distribution | |
| 60771-5 | In distribution | |
| 31206 | In distribution | |
| 30504 | In distribution | |
| 61043 | In distribution | |
| 70809 | In distribution | |
| 70511 | In distribution | |
| 30708 | In distribution | |
| 61230 | In distribution | |
| 30580 | In distribution | |
| 60641 | In distribution | |
| 60904-3 | In distribution | |
| 60950-3 | In distribution | |
| 30630 | In distribution | |
| 70410 | In distribution | |
| 30739 | In distribution | |
| 60967 | In distribution | |
| 30541 | In distribution | |
| 60537 | In distribution | |
| 61201-3 | In distribution | |
| 31211 | In distribution | |
| 60890 | In distribution | |
| 50905-DC | In distribution | |
| 60506 | In distribution | |
| 71130-3 | In distribution | |
| 30807 | In distribution | |
| 60660 | In distribution | |
| 61104-3 | In distribution | |
| 71021 | In distribution | |
| 31040 | In distribution | |
| 50505-DC | In distribution | |
| 60623 | In distribution | |
| 60748-3 | In distribution | |
| 60701-3 | In distribution | |
| 30675 | In distribution | |
| 65502-3 | In distribution | |
| 30209 | In distribution | |
| 60524 | In distribution | |
| 61066 | In distribution | |
| 61410 | In distribution | |
| 61111 | In distribution | |
| 30707 | In distribution | |
| 50500-DC | In distribution | |
| 60930 | In distribution | |
| 30315 | In distribution | |
| 50715-DC | In distribution | |
| 60740 | In distribution | |
| 51003-DC | In distribution | |
| 31234-5 | In distribution | |
| 30200 | In distribution | |
| 61020-5 | In distribution | |
| 30908-6 | In distribution | |
| 60708-5 | In distribution | |
| 60305 | In distribution | |
| 60521 | In distribution | |
| 65500-3 | In distribution | |
| 60689-5 | In distribution | |
| 31307 | In distribution | |
| 61330 | In distribution | |
| 60806 | In distribution | |
| 30310 | In distribution | |
| 61104 | In distribution | |
| 60825 | In distribution | |
| 61204-3 | In distribution | |
| 30521 | In distribution | |
| 30802 | In distribution | |
| 61210 | In distribution | |
| 30560 | In distribution | |
| 30501-5 | In distribution | |
| 65515-5 | In distribution | |
| 50900-DC | In distribution | |
| 60536 | In distribution | |
| 30445 | In distribution | |
| 60434 | In distribution | |
| 61129-5 | In distribution | |
| 30921 | In distribution | |
| 30794 | In distribution | |
| 30811 | In distribution | |
| 31016 | In distribution | |
| 30908 | In distribution | |
| 31125-3 | In distribution | |
| 51005-DC | In distribution | |
| 30800 | In distribution | |
| 30225 | In distribution | |
| 31154 | In distribution | |
| 31086 | In distribution | |
| 31070 | In distribution | |
| 61206 | In distribution | |
| 60620 | In distribution | |
| 31011-3 | In distribution | |
| 61040 | In distribution | |
| 61041 | In distribution | |
| 71020 | In distribution | |
| 30573 | In distribution | |
| 30706 | In distribution | |
| 61020-3 | In distribution | |
| 60800 | In distribution | |
| 60740-6 | In distribution | |
| 60750 | In distribution | |
| 30709 | In distribution | |
| 31106 | In distribution | |
| 71021-3 | In distribution | |
| 60700 | In distribution | |
| 60699-5 | In distribution | |
| 30813 | In distribution | |
| 61121-5 | In distribution | |
| 60560 | In distribution | |
| 60860 | In distribution | |
| 30894 | In distribution | |
| 71026 | In distribution | |
| 51013-DC | In distribution | |
| 60936-3 | In distribution | |
| 30500-5 | In distribution | |
| 51105-DC | Withdrawn | |
| 61407 | Withdrawn | |
| 61400 | Withdrawn | |
| 60820 | Withdrawn | |
| 31105-3 | Withdrawn | |
| 60500 | Withdrawn | |
| 30140C | Withdrawn | |
| 60740-6 | Withdrawn | |
| 61124 | Withdrawn | |
| 30418 | Withdrawn | |
| 61231-3 | 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 |
| 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 |
| 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.