Alere Icup Dx Pro
Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methamphetamine, Methadone, Opiate (300), Oxycodone and Tricyclic…
Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methamphetamine, Methadone, Opiate (300), Oxycodone and Tricyclic Antidepressants with adulteration tests for Oxidant, pH and Specific Gravity. CLIA Waived Test Cup
Who Else Makes It
Concentrated in Zhejiang (8), Guangdong (4), Tianjin (1). 3 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 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| 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 |
| Eterbio, Inc. | Zhuhai | Guangdong | Manufacturer | 29 |
| Safecare Biotech(Hangzhou)Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 22 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 16. All 16 manufacturers in China registered for Test, Cannabinoid, Over The Counter
Record
| Listed by | Instant Technologies, Inc. |
|---|---|
| FDA product code | NFW |
| Device type | Test, Cannabinoid, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3870 |
| 510(k) | K082898 |
| Record published | 2016-10-14 |
| Record revised | 2022-06-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I-DXP-1117-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover Plus | American Screening, L.L.C. | 47 |
| Discover | American Screening, L.L.C. | 43 |
| Precision DX | American Screening, L.L.C. | 42 |
| Reveal | American Screening, L.L.C. | 22 |
| OneScreen | American Screening, L.L.C. | 20 |
| Precision Plus | American Screening, L.L.C. | 12 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 8 |
| Exploro Highly Sensitive THC Test | Safecare Biotech(Hangzhou)Co., Ltd. | 6 |
| Analysis Oasis Marijuana (THC) Urine Strip Test | Safecare Biotech(Hangzhou)Co., Ltd. | 5 |
| Walgreens | Walgreen Co. | 4 |
| UScreen® | Instant Technologies, Inc. | 4 |
| VeriCheck Drug Test Dip | Verify Diagnostics Inc | 4 |
Showing 12 of 43. All products under Test, Cannabinoid, Over The Counter
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ameditech, Inc. | 510(k) number | 2017-09-30 | Class III | Nonconforming Material/Component | Product was released to market without the adulteration strip included in the product. | 40 kit boxes (1000 units) | 2019-08-06 |
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.