RealityCHECKTM
5 catalogue numbers from RC05AF, listed by Wolfe & Associates Inc, under Radioimmunoassay, Tricyclic Antidepressant Drugs. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
5catalogue 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 | Wolfe & Associates Inc |
|---|---|
| FDA product code | LFG |
| Device type | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3910 |
| Record published | 2016-09-26 |
| Record revised | 2022-06-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2018-09-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| RC05AF | 25 | Withdrawn | |
| RC05AC | 25 | Withdrawn | |
| RC05ACA | 25 | Withdrawn | |
| RC10KC | 25 | Withdrawn | |
| RC12KC | 25 | Withdrawn |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 |
| 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 |
| 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.