MIU — Enzyme Linked Immunosorbent Assay, T. Cruzi Class I
FDA Device Classification
Classification Details
- Product Code
- MIU
- Device Class
- Class I
- Regulation Number
- 866.3870
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K161947 | inbios international | Chagas Detect Plus Rapid Test | December 16, 2016 |
| K072732 | ortho-clinical diagnostics | ORTHO T. CRUZI ELISA TEST SYSTEM | April 15, 2009 |
| K023889 | wiener laboratories saic | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 | February 11, 2004 |
| K930272 | hemagen diagnostics | HEMAGEN CHAGAS' KIT (EIA METHOD) | May 19, 1995 |
| K933716 | abbott laboratories | ABBOTT CHAGAS ANTIBODY EIA | December 19, 1994 |
| K911233 | gull laboratories | CHAGAS' IGG ELISA TEST | May 4, 1992 |