Panels › Immunology › Product code LSW · Class 2
Anti-Dna Antibody, Antigen And Control
Regulation 866.5100
0510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LSW
| Company | 510(k)s | Recalls |
|---|---|---|
| Aesku Diagnostics | 3 | 0 |
| Phadia US, Inc. | 1 | 1 |
| Biomedical Diagnostics (Bmd) SA | 1 | 0 |
| Immco Diagnostics, Inc. | 1 | 0 |
| Immunodiagnostics, Ltd. | 1 | 0 |
| Inova Diagnostics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2021 | Phadia US Inc EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus Terminated |
LSW | K072393 |
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