Radioimmunoassay, Tricyclic Antidepressant Drugs
One Step Drug Screen Test Card (OX/SG/pH)+(NIT/GLUT/CRE) +COC300+AMP1000+mAMP1000 +THC50+MTD300+OPI2000+PCP25+BAR300+BZO300+TCA1000
9manufacturers in China registered for this device type
19catalogue numbers in this listing
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 | Alere San Diego, Inc., United States |
|---|---|
| FDA product code | LFG |
| Device type | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3910 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2026-03-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-09-18 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DOA-1127-041-19 | 25 | In distribution | |
| DOA-2104 | 25 | In distribution | |
| DOA-1105-051 | 25 | In distribution | |
| DOA-1124-011 | 25 | In distribution | |
| DOA-144-971 | 25 | In distribution | |
| DOA-1104 | 25 | In distribution | |
| DUD-1104-051 | 25 | In distribution | |
| DOA-1124-051 | 25 | In distribution | |
| DOA-1124-081 | 25 | In distribution | |
| DUE-167-711-19 | 25 | In distribution | |
| DTC-114 | 25 | In distribution | |
| DOA-1185 | 25 | In distribution | |
| DOA-11105 | 25 | In distribution | |
| DOA-1105-021 | 25 | In distribution | |
| DOA-144-991 | 25 | In distribution | |
| DOA-244 | 25 | Withdrawn | |
| DOA-364 | 25 | Withdrawn | |
| DOA-1364 | 25 | Withdrawn | |
| DOA-544 | 25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Healgen | Healgen Scientific Limited Liability Company | 96 |
| reditest® | Redwood Toxicology Laboratory, Inc. | 49 |
| iCup® | Instant Technologies, Inc. | 33 |
| Noble | Noble Medical Inc | 21 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | a. unk b. 6 c. 1 d. 1 e. 67 f. 1 g. 10 h. 51 i. 27 j. 105 k. |
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.