Panels › Immunology › Product code MVM · Class 2
Autoantibodies, Endomysial(Tissue Transglutaminase)
Regulation 866.5660
0510(k)s in 12 months (40 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MVM
| Company | 510(k)s | Recalls |
|---|---|---|
| Inova Diagnostics, Inc. | 12 | 0 |
| Immco Diagnostics, Inc. | 6 | 0 |
| The Binding Site | 3 | 0 |
| Scimedx Corp. | 3 | 0 |
| Euroimmun Us, Inc. | 2 | 0 |
| Hycor Biomedical , Ltd. | 2 | 0 |
| Phadia US, Inc. | 2 | 0 |
| Sqi Diagnostics Systems | 2 | 0 |
| Sweden Diagnostics (Germany) GmbH | 2 | 0 |
| Aesku, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2019 | Bio-Rad Labs Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive entero Completed |
MVM | K042644 |
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