Iscreen™
iScreen™ Urine Test CLIA Waived DX Drug Screen Square Cup 10 panel with SVTs (AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MOP300/OXY100/PCP25/THC50)+ SVT Cr, pH, S.G.
16manufacturers in China registered for this device type
31catalogue numbers in this listing
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, Amphetamine, Over The Counter
Record
| Listed by | Instant Technologies, Inc. |
|---|---|
| FDA product code | NFT |
| Device type | Test, Amphetamine, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3100 |
| 510(k) | K182701 |
| Record published | 2023-05-01 |
| Record revised | 2024-10-14 (version 4) |
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 4 to 30 °C |
| Packaging | Master carton of 4, master carton of 40, master carton of 20, pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ABTDUAW112705E | 25 | In distribution | |
| ABTDOAW17701A | 25 | In distribution | |
| ABTDUAW15702B | 25 | In distribution | |
| ABTDUAW112704D | 25 | In distribution | |
| ABTDUAW110702B | 25 | In distribution | |
| ABTDUAW17701A | 25 | In distribution | |
| ABTDOAK110701A | 25 | In distribution | |
| ABTDUAW110701A | 25 | In distribution | |
| ABTDUAK15701A | 25 | In distribution | |
| ABTDUAW113701A | 25 | In distribution | |
| ABTDUAW110703C | 25 | In distribution | |
| ABTDOAW110401A | 25 | In distribution | |
| ABTDUAW17703C | 25 | In distribution | |
| ABTDUAW110705E | 25 | In distribution | |
| ABTDUAW112706F | 25 | In distribution | |
| ABTDOAW15701A | 25 | In distribution | |
| ABTDOAW112401A | 25 | In distribution | |
| ABTDUAW111701A | 25 | In distribution | |
| ABTDOAW112402B | 25 | In distribution | |
| ABTDUAW15701A | 25 | In distribution | |
| ABTDOAK15701A | 25 | In distribution | |
| ABTDUAW112701A | 25 | In distribution | |
| ABTDUAW112703C | 25 | In distribution | |
| ABTDOAW112701A | 25 | In distribution | |
| ABTDOAW105401A | 25 | In distribution | |
| ABTDUAK110701A | 25 | In distribution | |
| ABTDUAW16701A | 25 | In distribution | |
| ABTDOAW14701A | 25 | In distribution | |
| ABTDUAW112702B | 25 | In distribution | |
| ABTDOAW105402B | 25 | In distribution | |
| ABTDUAW110704D | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover Plus | American Screening, L.L.C. | 59 |
| Precision DX | American Screening, L.L.C. | 42 |
| Discover | American Screening, L.L.C. | 32 |
| Reveal | American Screening, L.L.C. | 26 |
| Prime Screen | Wondfo USA Co., Ltd. | 20 |
| U-Catch | Shenzhen Bioeasy Biotechnology Co., Ltd. | 19 |
| SAFElife™ | Wondfo USA Co., Ltd. | 18 |
| DrugTect Multi-Drug Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 17 |
| Precision Plus | American Screening, L.L.C. | 12 |
| Rapid Response | Btnx Inc. | 11 |
| OneScreen | American Screening, L.L.C. | 9 |
| Discover Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 9 |
Showing 12 of 113. All products under Test, Amphetamine, Over The Counter
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.