Enzyme Linked Immunosorbent Assay, T. Cruzi
The ELISA for Trypanosoma cruzi (T. Cruzi) is an enzyme-linked immunosorbent assay used to detect antibodies against T. cruzi, the parasite responsible for Chagas disease, in patient serum, supporting screening and diagnosis of this chronic infectious disease. It is classified as a Class 1 device under 21 CFR 866.3870 within the Microbiology specialty and is subject only to general controls, with 510(k) exemption applicable. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MIU
- Device Class
- FDA class 1
- Regulation Number
- 866.3870
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K161947 | Chagas Detect Plus Rapid Test | Dec 16, 2016 | Substantially Equivalent | InBios International, Inc. |
| K072732 | ORTHO T. CRUZI ELISA TEST SYSTEM | Apr 15, 2009 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K023889 | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 | Feb 11, 2004 | Substantially Equivalent | Wiener Laboratories Saic |
| K930272 | HEMAGEN CHAGAS' KIT (EIA METHOD) | May 19, 1995 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K933716 | ABBOTT CHAGAS ANTIBODY EIA | Dec 19, 1994 | Substantially Equivalent | Abbott Laboratories |
| K911233 | CHAGAS' IGG ELISA TEST | May 04, 1992 | Substantially Equivalent | Gull Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.