Data / Medical devices / Antibody Igm,If, Cytomegalovirus Virus
Antibody Igm,If, Cytomegalovirus Virus (LKQ): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make Antibody Igm,If, Cytomegalovirus Virus (product code LKQ, Class 2, 21 CFR 866.3175). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on May 13, 2010, and lists 6 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- LKQ
- Device class
- 2
- Regulation
- 866.3175
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| France | 1 |
| United Kingdom | 1 |
Makers of Antibody Igm,If, Cytomegalovirus 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 |
|---|---|---|---|---|---|---|---|---|
| Biomerieux SA | MARCY L ETOILE Rhone, France | Manufacturer | 1 | August 2, 1994 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | April 26, 1990 | 0 | 0 | 0 | api.fda.gov |
| LGC Clinical Diagnostics, Inc. | Milford, MA, United States | Manufacturer | 1 | August 22, 1997 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 1 | May 13, 2010 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | May 13, 2010 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 1 | May 13, 2010 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 1 | April 26, 1990 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 13, 2010. 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.