ZDMC
Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd. · Model 1 test/kit · UDI-DI 06976045540242
1
510(k) clearances
3
Adverse events
3
Recalls
6
Facilities
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-05 | Quidel Corporation | There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test r |
| 2024-03-05 | Quidel Corporation | There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test r |
| 2017-06-22 | Quidel Corporation | In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.