DrugCheck
11 Panel Cup Drug Test, AMP500-BUP-BZO-COC150-EDDP300-MDMA-MET500-MTD-OPI300-OXY-THC-pH,SG,OX
18manufacturers in China registered for this device type
378catalogue 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 Diagnostics Int’l., Inc. |
|---|---|
| FDA product code | LDJ |
| Device type | Enzyme Immunoassay, Cannabinoids |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3870 |
| Record published | 2016-09-02 |
| Record revised | 2026-05-21 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 30 °C |
| Distribution end date | 2019-07-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60806 | In distribution | |
| 60500 | In distribution | |
| 60925 | In distribution | |
| 51005-DC | In distribution | |
| 30418 | In distribution | |
| 30140C | In distribution | |
| 65505-3 | In distribution | |
| 60820 | In distribution | |
| 61124 | In distribution | |
| 60890 | Withdrawn | |
| 31103 | Withdrawn | |
| 61010-5 | Withdrawn | |
| 61400 | Withdrawn | |
| 61040-3 | Withdrawn | |
| 60305 | Withdrawn | |
| 60812 | Withdrawn | |
| 60748-3 | Withdrawn | |
| 61231-3 | Withdrawn | |
| 61031 | Withdrawn | |
| 60921 | Withdrawn | |
| 61207-5 | Withdrawn | |
| 30504 | Withdrawn | |
| 60514-3 | Withdrawn | |
| 30779 | Withdrawn | |
| 60811 | Withdrawn | |
| 30970-5 | Withdrawn | |
| 61213 | Withdrawn | |
| 61028-3 | Withdrawn | |
| 61056-5 | Withdrawn | |
| 30529 | Withdrawn | |
| 30554 | Withdrawn | |
| 30410 | Withdrawn | |
| 61044 | Withdrawn | |
| 60828 | Withdrawn | |
| 60786 | Withdrawn | |
| 30209 | Withdrawn | |
| 31242 | Withdrawn | |
| 60526 | Withdrawn | |
| 30607 | Withdrawn | |
| 31105-3 | Withdrawn | |
| 61056-3 | Withdrawn | |
| 30302 | Withdrawn | |
| 60930 | Withdrawn | |
| 60902-3 | Withdrawn | |
| 61039-3 | Withdrawn | |
| 31028 | Withdrawn | |
| 61401 | Withdrawn | |
| 30573-3 | Withdrawn | |
| 30572-3 | Withdrawn | |
| 60601 | Withdrawn | |
| 30630-3 | Withdrawn | |
| 30708 | Withdrawn | |
| 60411 | Withdrawn | |
| 61106 | Withdrawn | |
| 60820-3 | Withdrawn | |
| 30541 | Withdrawn | |
| 31307 | Withdrawn | |
| 30401 | Withdrawn | |
| 61024 | Withdrawn | |
| 30802 | Withdrawn | |
| 31063 | Withdrawn | |
| 30612 | Withdrawn | |
| 31086 | Withdrawn | |
| 30660 | Withdrawn | |
| 60699-5 | Withdrawn | |
| 60802 | Withdrawn | |
| 61104-3 | Withdrawn | |
| 60722-3 | Withdrawn | |
| 60721-5 | Withdrawn | |
| 50700-DC | Withdrawn | |
| 60961-2 | Withdrawn | |
| 30436 | Withdrawn | |
| 61042 | Withdrawn | |
| 60821 | Withdrawn | |
| 31090 | Withdrawn | |
| 61211-3 | Withdrawn | |
| 30515 | Withdrawn | |
| 65505-5 | Withdrawn | |
| 61207 | Withdrawn | |
| 30696 | Withdrawn | |
| 30777 | Withdrawn | |
| 60623 | Withdrawn | |
| 31040 | Withdrawn | |
| 30608 | Withdrawn | |
| 61208-3 | Withdrawn | |
| 30902 | Withdrawn | |
| 61402-3 | Withdrawn | |
| 60700 | Withdrawn | |
| 61202-5 | Withdrawn | |
| 30213 | Withdrawn | |
| 60967 | Withdrawn | |
| 61006 | Withdrawn | |
| 60710 | Withdrawn | |
| 60505-3 | Withdrawn | |
| 60560 | Withdrawn | |
| 30450 | Withdrawn | |
| 60625 | Withdrawn | |
| 60706 | Withdrawn | |
| 61103 | Withdrawn | |
| 60611 | Withdrawn | |
| 30729 | Withdrawn | |
| 30816 | Withdrawn | |
| 60536 | Withdrawn | |
| 30650 BLK | Withdrawn | |
| 61129-5 | Withdrawn | |
| 31233 | Withdrawn | |
| 60640 | Withdrawn | |
| 60508 | Withdrawn | |
| 31208 | Withdrawn | |
| 30670 | Withdrawn | |
| 30434 | Withdrawn | |
| 30906 | Withdrawn | |
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| 30707 | Withdrawn | |
| 61100 | Withdrawn | |
| 60930-3 | Withdrawn | |
| 60400 | Withdrawn | |
| 60570 | Withdrawn | |
| 61123-3 | Withdrawn | |
| 31009 | Withdrawn | |
| 30604 | Withdrawn | |
| 31242-3 | Withdrawn | |
| 60621 | Withdrawn | |
| 60705-3 | Withdrawn | |
| 61121-5 | Withdrawn | |
| 30671 | Withdrawn | |
| 30206 | Withdrawn | |
| 30837 | Withdrawn | |
| 60875 | Withdrawn | |
| 31090-3 | Withdrawn | |
| 30503 | Withdrawn | |
| 30320 | Withdrawn | |
| 30894 | Withdrawn | |
| 30815 | Withdrawn | |
| 60630 | Withdrawn | |
| 60923 | Withdrawn | |
| 65520-5 | Withdrawn | |
| 60701 | Withdrawn | |
| 60514 | Withdrawn | |
| 31208-5 | Withdrawn | |
| 31228 | Withdrawn | |
| 31072 | Withdrawn | |
| 61134-3 | Withdrawn | |
| 31400 | Withdrawn | |
| 61121 | Withdrawn | |
| 60925-3 | Withdrawn | |
| 30980 | Withdrawn | |
| 50900-DC | Withdrawn | |
| 60505 | Withdrawn | |
| 61054 | Withdrawn | |
| 61045 | Withdrawn | |
| 31046 | Withdrawn | |
| 30675 | Withdrawn | |
| 31101 | Withdrawn | |
| 60512 | Withdrawn | |
| 31082 | Withdrawn | |
| 31207-3 | Withdrawn | |
| 65515 | Withdrawn | |
| 60866-3 | Withdrawn | |
| 60735-3 | Withdrawn | |
| 30630 | Withdrawn | |
| 30702 | Withdrawn | |
| 31300 | Withdrawn | |
| 30418 BLK | Withdrawn | |
| 60930-5 | Withdrawn | |
| 30140 | Withdrawn | |
| 30737 | Withdrawn | |
| 30415 | Withdrawn | |
| 61202-3 | Withdrawn | |
| 60221 | Withdrawn | |
| 31005-3 | Withdrawn | |
| 61093-2 | Withdrawn | |
| 60620-3 | Withdrawn | |
| 30420 | Withdrawn | |
| 30523 BLK | Withdrawn | |
| 30900 | Withdrawn | |
| 61023 | Withdrawn | |
| 30602 | Withdrawn | |
| 30709 | Withdrawn | |
| 30200 | Withdrawn | |
| 61002 | Withdrawn | |
| 61056-2 | Withdrawn | |
| 60410 | Withdrawn | |
| 31005 | Withdrawn | |
| 61206 | Withdrawn | |
| 30806 | Withdrawn | |
| 30445 | Withdrawn | |
| 31217 | Withdrawn | |
| 60929 | Withdrawn | |
| 31202-5 | Withdrawn | |
| 31073 | Withdrawn | |
| 61046 | Withdrawn | |
| 60903 | Withdrawn | |
| 60805 | Withdrawn | |
| 61105 | Withdrawn | |
| 60880 | Withdrawn | |
| 61215 | Withdrawn | |
| 30800 | Withdrawn | |
| 30310-3 | Withdrawn | |
| 31008 | Withdrawn | |
| 60641 | Withdrawn | |
| 31202 | Withdrawn | |
| 60711-5 | Withdrawn | |
| 30632 | Withdrawn | |
| 60931 | Withdrawn | |
| 61027 | Withdrawn | |
| 30600-3 | Withdrawn | |
| 61330 | Withdrawn | |
| 30601 | Withdrawn | |
| 30727 | Withdrawn | |
| 60788 | Withdrawn | |
| 60621-3 | Withdrawn | |
| 30843 | Withdrawn | |
| 61243-5 | Withdrawn | |
| 61020-5 | Withdrawn | |
| 30547 | Withdrawn | |
| 31091 | Withdrawn | |
| 30706 | Withdrawn | |
| 30805 | Withdrawn | |
| 60901 | Withdrawn | |
| 30312 | Withdrawn | |
| 61057 | Withdrawn | |
| 61048 | Withdrawn | |
| 65515-3 | Withdrawn | |
| 60660 | Withdrawn | |
| 31016 | Withdrawn | |
| 30500 | Withdrawn | |
| 60307 | Withdrawn | |
| 30695 | Withdrawn | |
| 31304 | Withdrawn | |
| 60703 | Withdrawn | |
| 30500-5 | Withdrawn | |
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| 60561 | Withdrawn | |
| 61022 | Withdrawn | |
| 30315 | Withdrawn | |
| 61021-5 | Withdrawn | |
| 61303 | Withdrawn | |
| 61103-3 | Withdrawn | |
| 31060 | Withdrawn | |
| 30606 | Withdrawn | |
| 30401-3 | Withdrawn | |
| 30429 | Withdrawn | |
| 60600 | Withdrawn | |
| 61204-3 | Withdrawn | |
| 61040 | Withdrawn | |
| 30726 | Withdrawn | |
| 30440 BLK | Withdrawn | |
| 60524 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.