Skip to the page
Get started free

Data / Medical devices / Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (LBS): 32 FDA-registered makers in 13 countries

32 establishments in 13 countries are registered with the FDA to make Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (product code LBS, Class 1, 21 CFR 862.1475). 13 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 80 510(k) clearances under this code, the latest on October 19, 2016, and lists 8 recall events (0 Class I). FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
LBS
Device class
1
Regulation
862.1475
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States17
Germany3
China2
United Kingdom1
Canada1
France1
Ireland1
Egypt1
Greece1
Switzerland1
Japan1
Taiwan1
Argentina1

Makers of Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer, Manufacturer, Repackager or relabeler3January 8, 2016000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer2September 7, 2012020api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer2September 7, 2012000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler, Specification developer2October 19, 2016000api.fda.gov
Sekisui Diagnostics P.E.I. Inc.CHARLOTTETOWN Prince Edward Island, CanadaContract manufacturer, Manufacturer2July 25, 2002000api.fda.gov
VitalScientificSEES Normandie, FranceManufacturer2August 31, 2011000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer1August 25, 2005000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesManufacturer, Repackager or relabeler1October 29, 2004000api.fda.gov
Diazyme Laboratories, Inc.Poway, CA, United StatesManufacturer1January 3, 2008000api.fda.gov
Hemagen Diagnostics, Inc.Baltimore, MD, United StatesManufacturer1August 13, 1987000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer1April 14, 2008000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer1October 28, 2004000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer1July 30, 1998000api.fda.gov
Abaxis, Inc.Union City, CA, United StatesManufacturer0000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesManufacturer0010api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer0010api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer0000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandManufacturer0010api.fda.gov
Dongguan Bao Kang Dian Zi Ke Ji LimitedDongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Elhoda Trade And SuppliesBadr industerial city Al Qahirah, EgyptManufacturer0000api.fda.gov
Home Access Health Corp.Hoffman Est, IL, United StatesManufacturer0000api.fda.gov
Immundiagnostik AGBensheim Hesse, GermanyManufacturer0000api.fda.gov
Medicon Hellas SAGERAKAS Attiki, GreeceManufacturer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.fda.gov
SEKISUI MEDICAL CO., LTD. Tsukuba PlantRyugasaki-shi Ibaraki, JapanContract manufacturer0000api.fda.gov
Shijiazhuang Hipro Biotechnology Co.,ltdShijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer0010api.fda.gov
TST Biomedical Electronics Co., Ltd.Taoyuan, TaiwanExporter to the US, Specification developer0000api.fda.gov
Wiener Laboratorios S.A.I.C.ROSARIO Santa Fe, ArgentinaManufacturer0000api.fda.gov

Updated October 19, 2016. 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.