ProScreen
Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+MDMA+MET1000+OPI300+OXY with Cr, Ni, pH, Bl, S.G.
16manufacturers in China registered for this device type
5catalogue numbers in this listing
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 | Instant Technologies, Inc. |
|---|---|
| FDA product code | DIO |
| Device type | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3250 |
| 510(k) | K052115 |
| Record published | 2019-10-14 |
| Record revised | 2022-06-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 30 °C; Storage environment temperature 36 to 86 °F |
| Distribution end date | 2020-12-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSCupA-5M-W | Withdrawn | |
| PSD-6MTDBO300 | Withdrawn | |
| PSDA-8MBO300 | Withdrawn | |
| PSD-10MOB | Withdrawn | |
| PSD-10MOX | Withdrawn |
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
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ameditech, Inc. | 510(k) number | 2020-08-18 | Class II | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. | 28,525 | 2024-09-30 |
| Ameditech, Inc. | 510(k) number | 2020-08-18 | Class II | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. | 41,340 units | 2024-09-30 |
| Ameditech, Inc. | 510(k) number | 2020-08-18 | Class II | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. | 537,120 units | 2024-09-30 |
| Ameditech, Inc. | 510(k) number | 2020-08-18 | Class II | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. | 99,900 units | 2024-09-30 |
| Ameditech, Inc. | 510(k) number | 2011-06-07 | Not classified | Packaging process control | The recall was initiated because Ameditech, Inc. received a complaint from US Diagnostics (USD) that First Check Drug Screen Cups were packaged in the ProScreen Cup boxes. Some of US Diagnostics’ customers received ProScreen 5-panel cups t | 2000 test cups (800 kits) | 2012-01-18 |
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.