Alere Icup Dx
Drugs of Abuse Test Cup for detection of BZO+BAR+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with adulteration tests Cr, Ni, pH, Bl, S.G., CLIA Waived
16manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (3), Beijing (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| 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 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
Showing 12 of 16. All 16 manufacturers in China registered for Enzyme Immunoassay, Amphetamine
Record
| Listed by | Instant Technologies, Inc. |
|---|---|
| FDA product code | DKZ |
| Device type | Enzyme Immunoassay, Amphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3100 |
| 510(k) | K052115 |
| Record published | 2016-09-19 |
| 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 36 to 86 °F; Storage environment temperature 2 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I-DXA-1117-131 | In distribution | |
| I-DXA-1127-023-N | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Healgen | Healgen Scientific Limited Liability Company | 69 |
| First Sign® | Hemosure Inc. | 39 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 38 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 21 |
| Advin Multi-Drug Screen Test | Advin Biotech, Inc. | 17 |
| T-Square | Wondfo USA Co., Ltd. | 15 |
| Enzyme Immunoassay, Amphetamine | W.h.p.m., Inc. | 15 |
| Statcup® II | Micro Distributing, L.C | 12 |
| MD DugScreen | Medical Disposables Corp | 12 |
| QuickProfile™ Drugs of Abuse Test Cup | Lumiquick Diagnostics, Inc. | 11 |
| Noble Drug Test Cup (Urine) | Noble Medical Inc | 10 |
| ECO II Cup ® | W.h.p.m., Inc. | 10 |
Showing 12 of 223. All products under Enzyme Immunoassay, Amphetamine
Recalls Naming This Product
83 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. | 28,525 | 2024-09-30 |
| 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. | 41,340 units | 2024-09-30 |
| 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. | 537,120 units | 2024-09-30 |
| 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. | 99,900 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 |
Showing 40 of 83.
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.