DrugSmart Cup
THC/COC/AMP/BZO/OPI/MET 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 | Twin Spirit Inc. |
|---|---|
| FDA product code | DJC |
| Device type | Thin Layer Chromatography, Methamphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3610 |
| 510(k) | K113501 |
| Record published | 2016-09-01 |
| Record revised | 2022-06-10 (version 6) |
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 |
| Distribution end date | 2018-06-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60600D | Withdrawn |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
79 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. | 3600 units | 2024-09-30 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 1,377 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 240 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 40 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 50 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 858 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 3,603 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 31,472 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 10,320 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 1,907 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 340 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 320 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 160 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 320 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 272 units | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 60 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 120 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 80 units | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 45,584 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 6,304 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 26 units | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 9,566 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 2,085 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 8,290 units | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 320 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 240 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 1,909 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 200 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 2,693 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 60 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 144 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 4,646 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 160 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 3,411 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 96 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 2,452 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 1,989 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 636 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 1200 kits | 2016-11-09 |
| Ameditech, Inc. | 510(k) number | 2015-11-16 | Class III | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compoun | 60 kits | 2016-11-09 |
Showing 40 of 79.
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.