AccuSign® Nicotine Card
AccuSign® Nicotine card; 35 Test Kit
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
All of them in Zhejiang. 2 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 |
Record
| Listed by | Princeton BioMeditech Corp., United States |
|---|---|
| FDA product code | MKU |
| Device type | Enzyme Immunoassay, Nicotine And Nicotine Metabolites |
| Device class | Class 1 |
| Regulation | 21 CFR 862.3220 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K062565 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DOA-217-35-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DRI Cotinine Assay | Microgenics Corporation | 3 |
| Auto-Lyte | Orasure Technologies, Inc. | 2 |
| LZI Cotinine II Enzyme Immunoassay | LIN-ZHI International, Inc. | 2 |
| DRI Cotinine Low Control | Microgenics Corporation | 1 |
| Kit, MP Cotinine Serum 100 plate | Orasure Technologies, Inc. | 1 |
| Nano-CheckTM Nicotine 500 | Nano-Ditech Corporation | 1 |
| Cotinine Serum 5 Plate Kit | Orasure Technologies, Inc. | 1 |
| DRI Cotinine High Control | Microgenics Corporation | 1 |
| Cotinine OraSure 100 Plate Kit | Orasure Technologies, Inc. | 1 |
| SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200) | Alere San Diego, Inc. | 1 |
| DRI Cotinine Calibrator Kit | Microgenics Corporation | 1 |
| Cotinine OraSure 5 Plate Kit | Orasure Technologies, Inc. | 1 |
Showing 12 of 17. All products under Enzyme Immunoassay, Nicotine And Nicotine Metabolites
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062565 | 2007-02-20 |
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.