Healgen
K243365 12 Panel Cup Type #31 with Low Cutoff and A3: AMP500, BAR300, BUP10, BZO300, COC150, MDMA500, MET500, MOP300, MTD300, OXY100, PCP25, THC50, +(OXI/SG/pH)
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (2), Beijing (1). 4 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 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Prometheus Bio Inc. | Hangzhou | Zhejiang | Contract manufacturer | 12 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
Record
| Listed by | Healgen Scientific Limited Liability Company |
|---|---|
| FDA product code | LFG |
| Device type | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3910 |
| Record published | 2026-02-04 |
| 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 |
| Storage | Storage environment temperature 2 to 30 °C |
| Packaging | Inner pack of 25, case of 4, case of 20, inner pack of 100, case of 50, case of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HDOA-254 | In distribution | |
| HCDOAV-454A3 | In distribution | |
| HDMD-101 | In distribution | |
| HDOA-1145 | In distribution | |
| HCDOAV-6125A3A | In distribution | |
| HCDOAV-164 | In distribution | |
| HCDOAEW-6125SA3 | In distribution | |
| HDOA-374 | In distribution | |
| HDED-114 | In distribution | |
| HCDOAEW-13104 | In distribution | |
| HDOP-201 | In distribution | |
| HCDOAEW-6125A3A | In distribution | |
| HCDOAV-5125A3A | In distribution | |
| HDOA-4105 | In distribution | |
| HCDOAV-154 | In distribution | |
| DOAY-5125 | In distribution | |
| HCDOA-8105A3 | In distribution | |
| HCDOAV-6125 | In distribution | |
| HDMD-114 | In distribution | |
| HDCO-101 | In distribution | |
| HDOA-574 | In distribution | |
| DOAY-6125A3 | In distribution | |
| HCDOAV-264A3 | In distribution | |
| HCDOAV-5125A3 | In distribution | |
| HCDOAV-4104 | In distribution | |
| HDBU-114 | In distribution | |
| HDOA-424 | In distribution | |
| HDOA-4964 | In distribution | |
| HCDOAV-1104S | In distribution | |
| HCDOAEC-6125A3 | In distribution | |
| HDMT-114 | In distribution | |
| HCDOAEW-8104 | In distribution | |
| DOAY-654 | In distribution | |
| DOAY-6125 | In distribution | |
| HDOA-6124 | In distribution | |
| HCDOAV-3124 | In distribution | |
| HCDOAV-275 | In distribution | |
| HCDOA-254 | In distribution | |
| HCDOAEW-264A3 | In distribution | |
| HDOA-535 | In distribution | |
| HCDOAEC-385 | In distribution | |
| HCDOAV-2145A3 | In distribution | |
| HCDOAEW-654 | In distribution | |
| HDOA-3104 | In distribution | |
| HCDOAV-254A3 | In distribution | |
| HDTC-114 | In distribution | |
| HDAM-114 | In distribution | |
| HDOA-164 | In distribution | |
| HCDOAV-855 | In distribution | |
| HDOA-865 | In distribution | |
| HDOA-184 | In distribution | |
| HCDOAV-265 | In distribution | |
| HCDOAV-7104 | In distribution | |
| HCDOAV-654A3 | In distribution | |
| HCDOAV-264 | In distribution | |
| HCDOAV-5125 | In distribution | |
| HCDOAV-6125A3 | In distribution | |
| HDPC-114 | In distribution | |
| HCDOAV-3104A3 | In distribution | |
| GBTHC-101a | In distribution | |
| HCDOAV-10115 | In distribution | |
| HCDOAEW-4105 | In distribution | |
| HDCO-114 | In distribution | |
| HCDOAV-564 | In distribution | |
| HCDOA-564 | In distribution | |
| HDOA-974N | In distribution | |
| HCDOAV-255 | In distribution | |
| DOAY-3124 | In distribution | |
| HDOX-201 | In distribution | |
| HCDOAV-3124 | In distribution | |
| HCDOAV-6124A3 | In distribution | |
| HCDOAV-254 | In distribution | |
| HCDOAV-274A3 | In distribution | |
| HDTH-101 | In distribution | |
| HCDOAEW-8105 | In distribution | |
| HCDOAV-10115S | In distribution | |
| HCDOAV-6125SA3A | In distribution | |
| HCDOA-5125 | In distribution | |
| HCDOAF-4104 | In distribution | |
| HCDOAV-4105 | In distribution | |
| HCDOA-955 | In distribution | |
| HDOA-1104C | In distribution | |
| HCDOAV-564 | In distribution | |
| HDOA-4104 | In distribution | |
| HCDOAV-3104 | In distribution | |
| HCDOAV-275S | In distribution | |
| HDOA-264 | In distribution | |
| HCDOAV-2135A3 | In distribution | |
| HCDOAV-654 | In distribution | |
| HCDOAV-6125SA3 | In distribution | |
| HCDOAV-334 | In distribution | |
| HDTC-114 | In distribution | |
| HDOA-7104 | In distribution | |
| HCDOAV-274 | In distribution | |
| HCDOAV-2145 | In distribution | |
| HCDOAV-1265 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| reditest® | Redwood Toxicology Laboratory, Inc. | 49 |
| iCup® | Instant Technologies, Inc. | 33 |
| Noble | Noble Medical Inc | 21 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | Alere San Diego, Inc. | 19 |
| MD DugScreen | Medical Disposables Corp | 15 |
| DTX® | ONE Step Detex Associates | 14 |
| accutest® | Jant Pharmacal Corp. | 13 |
| AlereTM iScreen® | Instant Technologies, Inc. | 11 |
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| Advin Multi-Drug Screen Test | Advin Biotech, Inc. | 6 |
| RealityCHECKTM | Wolfe & Associates Inc | 5 |
| Express ResultsTM | Quest Diagnostics, Inc. | 5 |
Showing 12 of 85. All products under Radioimmunoassay, Tricyclic Antidepressant Drugs
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.