Healgen
K243365 14 Panel Cup Type #22 with Clicker and 3AD: AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, OXY100, PCP25, PPX300, TCA1000, THC50 +(OXI/SG/pH)
16manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (3), Beijing (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Assure Tech. (Hangzhou) 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 16. All 16 manufacturers in China registered for Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Record
| Listed by | Healgen Scientific Limited Liability Company |
|---|---|
| FDA product code | DIO |
| Device type | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3250 |
| Record published | 2025-12-19 |
| Record revised | 2022-06-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 2 to 30 °C |
| Packaging | Inner pack of 25, case of 4, case of 20, case of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HDMT-114 | In distribution | |
| HDOA-124 | In distribution | |
| HCDOAV-264A3 | In distribution | |
| HCDOAV-654 | In distribution | |
| HCDOAF-4104 | In distribution | |
| HCDOAF-654 | In distribution | |
| HDOA-234 | In distribution | |
| HCDOAF-6124 | In distribution | |
| HCDOAEW-6125A3 | In distribution | |
| HCDOAF-6125 | In distribution | |
| HCDOAA-154 | In distribution | |
| HDOA-8104 | In distribution | |
| HCDOAF-664A6 | In distribution | |
| HDOA-144 | In distribution | |
| HDOA-154 | In distribution | |
| HCDOAF-8104 | In distribution | |
| HDBA-114 | In distribution | |
| HCDOAEW-4104 | In distribution | |
| HCDOAV-1144A3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| iCup® | Instant Technologies, Inc. | 15 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 12 |
| AlereTM iScreen® | Instant Technologies, Inc. | 9 |
| MD DugScreen | Medical Disposables Corp | 9 |
| Monitect Drug Screen Cassette Test | Branan Medical Corporation | 9 |
| First Sign® | Hemosure Inc. | 8 |
| Rapid Response | Btnx Inc. | 7 |
| Identify® Diagnostics Drug Test Cards | Medical Distribution Group Inc | 7 |
| iScreen™ | Instant Technologies, Inc. | 7 |
| SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup | Alere San Diego, Inc. | 7 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 7 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | W.h.p.m., Inc. | 7 |
Showing 12 of 152. All products under Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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.