LBS

Product Code: LBS

Products Classified as LBS

600

Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

Lipoprotein Test System.

Total Product Life Cycle (TPLC) Devices

600

Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

Lipoprotein Test System.

FDA Consensus Standards

• Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl [11555]: 21 CFR §862.1475 🔎

Pre-market Notifications for LBS

K162593	HDL-Cholesterol Gen.4	Roche Diagnostics Operations (RDO)
K153435	Direct HDL Cholesterol (HDL)	Randox Laboratories Ltd
K132711	CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT	CAROLINA LIQUID CHEMISTRIES CORP.
K120609	VITROS CHEMISTRY PRODUCTS DHDL SLIDES	Ortho-Clinical Diagnostics, Inc.
K111516	NMR LIPOPROFILE (R) TEST AND NMR PROFILER	LIPOSCIENCE, INC
K111036	EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT	MEDICA CORPORATION
K103747	ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS	ELITECHGROUP SEPPIM S.A.S.
K100550	POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC	POLYMEDCO, INC.
K100010	HDL CHOLESTEROL (HDLX) ASSAY	BECKMAN COULTER, INC.
K080125	APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201	WAKO CHEMICALS USA, INC.
K073497	HDL CHOLESTEROL REAGENT, MODEL 10211	MEDICA CORP.
K072836	CHOLESTRAK HDL CHOLESTEROL HOME TEST	ACCUTECH, LLC.
K072395	DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS	DIAZYME LABORATORIES
K071706	ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)	CLINICAL DATA, INC.
K062092	PREVU POINT OF CARE SKIN STEROL TEST	PREMD, INC.

Global Unique Device Identification Database

• 00380740129996: LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL
• 00380740129989: LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL
• 00380740005313: LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL
• 00628063400614: LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL
• 00628063400591: LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL
• 00628063400584: LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL
• 00628063400553: LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL
• 00628063400546: LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL
• 00657498001561: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
• 00657498000694: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
• 00657498000687: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
• 00657498000670: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
• 00812137012067: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
• 00817302023060: LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL
• 00817302022216: LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL

Maude Adverse Events

HDL-CHOLESTEROL GEN.4	ROCHE DIAGNOSTICS	2019-09-17
HDL-CHOLESTEROL GEN.4	ROCHE DIAGNOSTICS	2019-08-05
HDL-C GEN.4	ROCHE DIAGNOSTICS	2017-12-14
HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION	ROCHE DIAGNOSTICS	2017-10-09
HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION	ROCHE DIAGNOSTICS	2017-08-24
COBAS 8000 C 702 MODULE	ROCHE DIAGNOSTICS	2017-08-16
COBAS 8000 C 702 MODULE	ROCHE DIAGNOSTICS	2017-08-10
ANALYTICAL D MODULE	ROCHE DIAGNOSTICS	2017-08-10
COBAS 8000 C 702 MODULE	ROCHE DIAGNOSTICS	2017-08-07
ANALYTICAL D MODULE	ROCHE DIAGNOSTICS	2017-08-07
COBAS 6000 C501 MODULE	ROCHE DIAGNOSTICS	2017-08-01
ADVIA CHEMISTRY XPT	SIEMENS HEALTHCARE DIAGNOSTICS INC.	2017-06-27
COBAS 8000 C 702 MODULE	ROCHE DIAGNOSTICS	2017-06-02
HDLC HDL-CHOLESTEROL PLUS 3RD GENERATION	ROCHE DIAGNOSTICS	2017-05-18
DIMENSION VISTA 1500	SIEMENS HEALTHCARE DIAGNOSTICS INC.	2017-04-22
DIMENSION EXL 200	SIEMENS HEALTHCARE DIAGNOSTICS INC.	2017-04-05
COBAS 6000 C501 MODULE	ROCHE DIAGNOSTICS	2017-03-14
DIMENSION EXL 200	SIEMENS HEALTHCARE DIAGNOSTICS INC.	2017-02-21
HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION	ROCHE DIAGNOSTICS	2016-08-31
COBAS 6000 C501 MODULE	ROCHE DIAGNOSTICS	2011-11-17
HDL-C PLUS 3RD GENERATION	ROCHE DIAGNOSTICS	2011-07-27
SYNCHRON? LD	BECKMAN COULTER INC.	2011-05-19
SYNCHRON? HDLD CHOLESTEROL REAGENT	BECKMAN COULTER INC.	2010-12-29
COBAS 6000 C501MODULE	ROCHE DIAGNOSTICS	2010-12-03
DIRECT LDL CHOLESTEROL REAGENT (REF 989706)	BECKMAN COULTER	2006-09-18
DIRECT LDL CHOLESTEROL REAGENT (REF 969706)	BECKMAN COULTER	2006-09-18
DIRECT LDL CHOLESTEROL REAGENT (REF 989706)	BECKMAN COULTER	2006-09-18
DIRECT LDL CHOLESTEROL REAGENT (REF 969706)	BECKMAN COULTER	2006-09-18
EQUAL -GENZYME- DIRECT LDL REAGENT ON DADE DIMENSION RXL	GENZYME	2001-10-24
DMA ONE-SHOTS HDL PRECIPITATING REAGENT	DATA MEDICAL ASSOCIATES, INC. (DMA)	1996-12-05