MRR

Product Code: MRR


Products Classified as MRR

618System, Test, Low Density, LipoproteinLipoprotein Test System.

Total Product Life Cycle (TPLC) Devices

618System, Test, Low Density, LipoproteinLipoprotein Test System.

FDA Consensus Standards

System, Test, Low Density, Lipoprotein [11555]21 CFR §862.1475 🔎

Pre-market Notifications for MRR

K161691Direct LDL Cholesterol (LDL)RANDOX LABORATORIES LIMITED
K091333S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022ALFA WASSERMANN, INC.
K090734EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTESMEDICA CORP.
K063841NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLSLIPOSCIENCE
K051121DIRECT LDL CHOLESTEROL, MODEL L530-60HTECO DIAGNOSTICS
K043264LDL-EX SEIKEN ASSAY KITDENKA SEIKEN CO., LTD.
K041720VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND IIOrtho-Clinical Diagnostics, Inc.
K040693PTS PANELS LDL CHOLESTEROL TEST STRIPSPOLYMER TECHNOLOGY SYSTEMS, INC.
K022772RAICHEM LDL-CHOLESTEROL DIRECT REAGENTHEMAGEN DIAGNOSTICS, INC.
K020724DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131DADE BEHRING, INC.
K020575ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITSELAN DIAGNOSTICS
K014103SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATORBECKMAN COULTER, INC.
K012287MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATIONROCHE DIAGNOSTICS CORP.
K993741EZ LDL CHOLESTEROL TEST SYSTEMSIGMA DIAGNOSTICS, INC.
K992766N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SETGENZYME CORP.

Global Unique Device Identification Database

00628063400775SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN
00628063400768SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN
00628063400751SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN
00628063400737SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN
00628063400720SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN
00657498001578System, Test, Low Density, Lipoprotein
00657498000700System, Test, Low Density, Lipoprotein
00811727015082System, Test, Low Density, Lipoprotein
00811727013637System, Test, Low Density, Lipoprotein
00811727013071System, Test, Low Density, Lipoprotein
00811727011787System, Test, Low Density, Lipoprotein
00811727011770System, Test, Low Density, Lipoprotein
00811727011763System, Test, Low Density, Lipoprotein
00817439021021System, Test, Low Density, Lipoprotein
00817439021014System, Test, Low Density, Lipoprotein

Maude Adverse Events

LDL_C LDL-CHOLESTEROL PLUS 3ND GENERATIONROCHE DIAGNOSTICS2020-02-18
PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZERPOLYMER TECHNOLOGY SYSTEMS INC2018-12-17
PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZERPOLYMER TECHNOLOGY SYSTEMS INC2018-12-17
PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZERPOLYMER TECHNOLOGY SYSTEMS INC2018-12-17
LDL_C LDL-CHOLESTEROL PLUS 2ND GENERATIONROCHE DIAGNOSTICS2018-07-30
LDL_C LDL-CHOLESTEROL PLUS 3ND GENERATIONROCHE DIAGNOSTICS2017-10-04
LDL_C LDL-CHOLESTEROL PLUS 3ND GENERATIONROCHE DIAGNOSTICS2017-08-24
LDL_C LDL-CHOLESTEROL PLUS 2ND GENERATIONROCHE DIAGNOSTICS2017-05-18
SYNCHRON? SYSTEMS DIRECT LDL CHOLESTEROL REAGENTBECKMAN COULTER INC.2011-12-20
LDLD (LDL CHOLESTEROL) REAGENTBECKMAN COULTER, INC.2011-09-08
LDLD REAGENTBECKMAN COULTER INC.2011-05-02
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