Home › Device types › LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
FDA product code LBS · Class 1 · Clinical Chemistry
74
Registered devices
33
Adverse events
9
Recalls
80
510(k) clearances
Devices with this code
HDL Ultra Cholesterol — SEKISUI DIAGNOSTICS, LLCNMR Reference Standard — Labcorp of AmericaAlere Cholestech LDX® — Alere San Diego, Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Alinity — Abbott GmbHJAS Diagnostics — DREW SCIENTIFIC, INC.Ultra N-geneous HDL Cholesterol Reagent — SEKISUI DIAGNOSTICS, LLCCholestech LDX™ — Alere San Diego, Inc.DIRECT HDL-CHOLESTEROL (HDL) — RANDOX LABORATORIES LIMITEDCAROLINA LIQUID CHEMISTRIES CORP.® HDL RGT. KIT BL-616 — CAROLINA LIQUID CHEMISTRIES CORPORATIONNMR Diluent 1 — Labcorp of AmericaCAROLINA LIQUID CHEMISTRIES CORP.® HDL DIRECT CC615 — CAROLINA LIQUID CHEMISTRIES CORPORATIONAlinity — Abbott GmbHAU — Beckman Coulter, Inc.ox-LDL ELISA — Immundiagnostik AGADVIA® Chemistry D-HDL Direct HDL Cholesterol Reagents — Siemens Healthcare Diagnostics Inc.Synermed® — INFRARED LABORATORY SYSTEMS LLCAlere Cholestech LDX® — Alere San Diego, Inc.Ultra N-geneous HDL Cholesterol Reagent — SEKISUI DIAGNOSTICS, LLCClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol — CLEARCHEM DIAGNOSTICS INC.Atellica™ CH D-HDL — Siemens Healthcare Diagnostics Inc.Direct HDL Cholesterol LiquiColor® — STANBIO LABORATORY, L.P.HDL-Cholesterol Gen.4 — Roche Diagnostics GmbHADVIA® Chemistry D-HDL Direct HDL Cholesterol Reagents — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-08 | Beckman Coulter Ireland, Inc. | Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent s |
| 2017-04-03 | Beckman Coulter Inc. | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result |
| 2016-08-02 | Alere San Diego, Inc. | Incorrect expiration date on the magnetic strip that does not match the labeled expiration date. |
| 2016-03-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. |
| 2015-05-07 | Roche Diagnostics Operations, Inc. | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests |
| 2015-05-07 | Roche Diagnostics Operations, Inc. | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 2012-02-02 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type. |
| 2008-06-11 | Roche Diagnostics Corp. | Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. |
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