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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 16, 2016 | K161947 | Chagas Detect Plus Rapid Test InBios International, Inc. | MIU |
| Apr 15, 2009 | K072732 | ORTHO T. CRUZI ELISA TEST SYSTEM Ortho-Clinical Diagnostics, Inc. | MIU |
| Feb 11, 2004 | K023889 | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 Wiener Laboratories Saic, AR | MIU |
| May 19, 1995 | K930272 | HEMAGEN CHAGAS' KIT (EIA METHOD) Hemagen Diagnostics, Inc. | MIU |
| Dec 19, 1994 | K933716 | ABBOTT CHAGAS ANTIBODY EIA Abbott Laboratories | MIU |
| May 4, 1992 | K911233 | CHAGAS' IGG ELISA TEST Gull Laboratories, Inc. | MIU |
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