Data / Medical devices / Enzyme Linked Immunosorbent Assay, T. Cruzi
Enzyme Linked Immunosorbent Assay, T. Cruzi (MIU): 11 FDA-registered makers in 2 countries
11 establishments in 2 countries are registered with the FDA to make Enzyme Linked Immunosorbent Assay, T. Cruzi (product code MIU, Class 1, 21 CFR 866.3870). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on December 16, 2016, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- MIU
- Device class
- 1
- Regulation
- 866.3870
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Argentina | 1 |
Makers of Enzyme Linked Immunosorbent Assay, T. Cruzi
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 2 | December 16, 2016 | 0 | 0 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 1 | May 19, 1995 | 0 | 0 | 0 | api.fda.gov |
| Inbios International, Inc. | Seattle, WA, United States | Manufacturer, Manufacturer for export | 1 | December 16, 2016 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Raritan, NJ, United States | Complaint file establishment, Manufacturer | 1 | April 15, 2009 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | April 15, 2009 | 0 | 0 | 0 | api.fda.gov |
| Wiener Laboratorios S.A.I.C. | ROSARIO Santa Fe, Argentina | Manufacturer | 1 | February 11, 2004 | 0 | 0 | 0 | api.fda.gov |
| Chembio Diagnostic Systems, Inc. | Medford, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chembio Diagnostic Systems | Bay Shore, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eiger Diagnostics, Inc. | Las Vegas, NV, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keva Inc. | Blaine, WA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 16, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.