AlereTM Iscreen®
11 catalogue numbers from IS9, listed by Instant Technologies, Inc., under Radioimmunoassay, Tricyclic Antidepressant Drugs. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
11catalogue 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 | Instant Technologies, Inc. |
|---|---|
| FDA product code | LFG |
| Device type | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3910 |
| Record published | 2016-09-24 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IS9 | 25 | In distribution | |
| IS2CT | 25 | In distribution | |
| IS3OCT | 25 | In distribution | |
| IS1TCA | 25 | In distribution | |
| IS5M | 25 | In distribution | |
| IS6B | 25 | In distribution | |
| I-DUE-164-161 | 25 | In distribution | |
| IS8 | 25 | In distribution | |
| I-DOA-194-191 | 25 | In distribution | |
| IS5MP | 25 | In distribution | |
| IS4M | 25 | In distribution |
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 |
| 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.