Cedia Cocaine Assay
3 catalogue numbers from 10016413, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Cocaine And Cocaine Metabolites. 16 manufacturers in China are registered for this product code.
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 | Microgenics Corporation, United States |
|---|---|
| FDA product code | DIO |
| Device type | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3250 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-22 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10016413 | In distribution | |
| 100086 | In distribution | |
| 100095 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Healgen | Healgen Scientific Limited Liability Company | 19 |
| 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 |
Showing 12 of 152. All products under Enzyme Immunoassay, Cocaine And Cocaine Metabolites
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211973 | 2021-09-24 |
| K181499 | 2018-07-06 |
| K101742 | 2011-04-08 |
| K945345 | 1995-01-17 |
| K941310 | 1994-06-02 |
| K935904 | 1994-03-11 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-07-23 | Class II | Under Investigation by firm | Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation. | 1473 units in distribution. | 2013-12-02 |
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.