AmediCheck Instant Test Cup
THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MTD, TCA, OXY Drugs of Abuse Test Cup
12manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (8), Beijing (2), Guangdong (2). 6 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 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| 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 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Hangzhou Clongene Biotech Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 21 |
| Hangzhou Laihe Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 10 |
Record
| Listed by | Ameditech, Inc., United States |
|---|---|
| FDA product code | DJC |
| Device type | Thin Layer Chromatography, Methamphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3610 |
| 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| C-60B02 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Advin Multi-Drug Screen Test | Advin Biotech, Inc. | 14 |
| First Sign® | Hemosure Inc. | 10 |
| Rapid Response | Btnx Inc. | 6 |
| Fastect II Drug Screen Dipstick Test | Branan Medical Corporation | 6 |
| Identify Health | Medical Distribution Group Inc | 5 |
| ProScreen | Instant Tech Subsidiary Acquisition | 5 |
| UCP Home Drug Screening Test Cards | UCP Biosciences, Inc. | 5 |
| Thin Layer Chromatography, Methamphetamine | Chemtron Biotech, Inc. | 3 |
| QuickProfile™ Drugs of Abuse Panel 7 Test | Lumiquick Diagnostics, Inc. | 3 |
| SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup | Alere San Diego, Inc. | 3 |
| Identify Diagnostics USA | Medical Distribution Group Inc | 3 |
| ImmuTest Drugs of Abuse Screen Card | Ameditech, Inc. | 3 |
Showing 12 of 87. All products under Thin Layer Chromatography, Methamphetamine
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.