ImmuTest Drugs of Abuse Screen Card
Benzodiazepine single drug dipcard
13manufacturers in China registered for this device type
1catalogue number
40recalls on this code
Who Else Makes It
Concentrated in Zhejiang (7), Guangdong (3), Beijing (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Prometheus Bio Inc. | Hangzhou | Zhejiang | Contract manufacturer | 12 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou AllTest Biotech 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 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Hangzhou Clongene Biotech Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 21 |
Showing 12 of 13. All 13 manufacturers in China registered for Enzyme Immunoassay, Benzodiazepine
Record
| Listed by | Ameditech, Inc., United States |
|---|---|
| FDA product code | JXM |
| Device type | Enzyme Immunoassay, Benzodiazepine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3170 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K113046 |
| Record published | 2016-09-01 |
| Record revised | 2023-11-14 (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 | 2018-04-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IMD-BZO | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MD DugScreen | Medical Disposables Corp | 27 |
| First Sign® | Hemosure Inc. | 26 |
| MD DrugScreen | Medical Disposables Corp | 20 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 17 |
| Statdip® | Micro Distributing, L.C | 17 |
| Statcup® II | Micro Distributing, L.C | 16 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 15 |
| Healgen | Healgen Scientific Limited Liability Company | 13 |
| QuickProfile™ Drugs of Abuse Test Cup | Lumiquick Diagnostics, Inc. | 11 |
| ECO™ Cup | W.h.p.m., Inc. | 8 |
| ECO™ II Cup | W.h.p.m., Inc. | 8 |
| U-Screen | Instant Tech Subsidiary Acquisition | 7 |
Showing 12 of 145. All products under Enzyme Immunoassay, Benzodiazepine
Recalls Naming This Product
78 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 | 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 |
| 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 | 338 kits | 2016-11-09 |
Showing 40 of 78.
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.