Zdmc
This kit is intended for qualitative detection of the matrix metalloproteinase-9 (MMP-9) in human ocular surface rinsing fluid for the auxiliary diagnosis of dry eye disease.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd., China |
|---|---|
| FDA product code | PFQ |
| Device type | Mmp-9 Test System |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1540 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-03-17 |
| Record revised | 2023-05-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 test/kit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| InflammaDry | Quidel Corp. | 1 |
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.