Data / Medical devices / Enzyme Linked Immunoabsorbent Assay, Rotavirus
Enzyme Linked Immunoabsorbent Assay, Rotavirus (LIQ): 12 FDA-registered makers in 3 countries
12 establishments in 3 countries are registered with the FDA to make Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ, Class 1, 21 CFR 866.3405). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 33 510(k) clearances under this code, the latest on August 9, 1999, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LIQ
- Device class
- 1
- Regulation
- 866.3405
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| South Korea | 1 |
| United Kingdom | 1 |
Makers of Enzyme Linked Immunoabsorbent Assay, Rotavirus
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 |
|---|---|---|---|---|---|---|---|---|
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 2 | August 20, 1997 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | August 8, 1997 | 0 | 0 | 0 | api.fda.gov |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boditech Med Inc. | Chuncheon Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer for export | 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 | |
| Lumiquick Diagnostics, Inc. | Santa Clara, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sekisui Diagnostics, LLC | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 9, 1999. 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.