Data / Medical devices / Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (LHL): 9 FDA-registered makers in 2 countries
9 establishments in 2 countries are registered with the FDA to make Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (product code LHL, Class 2, 21 CFR 866.3300). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on January 11, 1999, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LHL
- Device class
- 2
- Regulation
- 866.3300
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Canada | 1 |
Makers of Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
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 |
|---|---|---|---|---|---|---|---|---|
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 5 | June 18, 1997 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Manufacturer | 1 | August 22, 1985 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Manufacturer | 1 | August 22, 1985 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | February 16, 1983 | 0 | 0 | 0 | api.fda.gov |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quidel Corp. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| pro-lab incorporated | Richmond Hill Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 11, 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.