Data / Medical devices / Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl / United States
FDA-registered makers of Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (product code LBS). 9 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- Product code
- LBS
- Country
- United States
Makers of Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 2 | September 7, 2012 | 0 | 2 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 2 | September 7, 2012 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 1 | August 25, 2005 | 0 | 0 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer, Repackager or relabeler | 1 | October 29, 2004 | 0 | 0 | 0 | api.fda.gov |
| Diazyme Laboratories, Inc. | Poway, CA, United States | Manufacturer | 1 | January 3, 2008 | 0 | 0 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 1 | August 13, 1987 | 0 | 0 | 0 | api.fda.gov |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 1 | April 14, 2008 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 1 | October 28, 2004 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | July 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Abaxis, Inc. | Union City, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alere San Diego, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Home Access Health Corp. | Hoffman Est, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov |
Updated November 2, 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.