Data / Medical devices / Giardia Spp. / United States
FDA-registered makers of Giardia Spp. in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Giardia Spp. (product code MHI). 6 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 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.
- Device
- Giardia Spp.
- Product code
- MHI
- Country
- United States
Makers of Giardia Spp. in the United States
| 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 | March 5, 2003 | 0 | 0 | 0 | api.fda.gov |
| Medical Chemical Corporation | Torrance, CA, United States | Manufacturer, Repackager or relabeler | 2 | March 5, 2003 | 0 | 0 | 0 | api.fda.gov |
| Remel, Inc. | Lenexa, KS, United States | Manufacturer | 2 | November 18, 2003 | 0 | 3 | 0 | api.fda.gov |
| Techlab, Inc. | Radford, VA, United States | Manufacturer | 2 | August 18, 2011 | 0 | 0 | 0 | api.fda.gov |
| Techlab, Inc. | Blacksburg, VA, United States | Manufacturer | 2 | August 18, 2011 | 0 | 0 | 0 | api.fda.gov |
| Sekisui Diagnostics, LLC | San Diego, CA, United States | Manufacturer, Repackager or relabeler | 1 | January 11, 1999 | 0 | 1 | 0 | api.fda.gov |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivd Research, LLC. | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.