Data / Medical devices / Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus (MZO): 14 FDA-registered makers in 5 countries
14 establishments in 5 countries are registered with the FDA to make Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus (product code MZO, Class 2, 21 CFR 866.3169). 11 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on September 23, 2026, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MZO
- Device class
- 2
- Regulation
- 866.3169
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Germany | 2 |
| United Kingdom | 2 |
| Italy | 1 |
| Japan | 1 |
Makers of Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
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 |
|---|---|---|---|---|---|---|---|---|
| ABBOTT GmbH | Wiesbaden Hesse, Germany | Manufacturer | 2 | September 23, 2026 | 1 | 1 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 1 | January 4, 2023 | 2 | 0 | 0 | api.fda.gov |
| DiaSorin Italia S.p.A UK Branch | Dartford Kent, United Kingdom | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| DiaSorin Italia S.p.A. | SALUGGIA Vercelli, Italy | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Orasure Technologies Inc. | Bethlehem, PA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Orasure Technologies, Inc. | Bethlehem, PA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Orasure Technologies, Inc. | Bethlehem, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 23, 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.