AmediCheck Instant Test Cup
COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY Drugs of Abuse Test Cup
16manufacturers in China registered for this device type
2catalogue 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, Cocaine And Cocaine Metabolites, Over The Counter
Record
| Listed by | Ameditech, Inc., United States |
|---|---|
| FDA product code | NFY |
| Device type | Test, Cocaine And Cocaine Metabolites, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3250 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K063379 |
| Record published | 2017-03-31 |
| Record revised | 2023-11-14 (version 7) |
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 |
| Distribution end date | 2020-10-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C-C0503A-3A | Withdrawn | |
| C-C1102A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover | American Screening, L.L.C. | 36 |
| Discover Plus | American Screening, L.L.C. | 33 |
| Precision DX | American Screening, L.L.C. | 26 |
| Precision Plus | American Screening, L.L.C. | 12 |
| Reveal | American Screening, L.L.C. | 12 |
| Rapid Response | Btnx Inc. | 8 |
| OneScreen | American Screening, L.L.C. | 8 |
| Discover Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 5 |
| DrugConfirm | Confirm Biosciences LLC | 2 |
| Rite Aid | Rite AID Corporation | 2 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 2 |
| Identify Diagnostics Multi-Drug Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2 |
Showing 12 of 42. All products under Test, Cocaine And Cocaine Metabolites, Over The Counter
Recalls Naming This Product
2 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 | 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 |
| Branan Medical Corporation | 510(k) number | 2016-07-05 | Class III | Labeling mix-ups | Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error. | 96 units | 2016-10-04 |
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.