Panels › Microbiology › Product code MIU · Class 1
Enzyme Linked Immunosorbent Assay, T. Cruzi
Regulation 866.3870
0510(k)s in 12 months (6 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MIU
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 1 | 0 |
| Gull Laboratories, Inc. | 1 | 0 |
| Hemagen Diagnostics, Inc. | 1 | 0 |
| InBios International, Inc. | 1 | 0 |
| Ortho-Clinical Diagnostics, Inc. | 1 | 0 |
| Wiener Laboratories | 0 | 1 |
| Wiener Laboratories Saic | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2017 | Wiener Laboratories Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0
Diagnosis of Chagas disease. Open, Classified |
MIU | K023889 |
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