LBR

Product Code: LBR


Products Classified as LBR

599Ldl & Vldl Precipitation, HdlLipoprotein Test System.

Total Product Life Cycle (TPLC) Devices

599Ldl & Vldl Precipitation, HdlLipoprotein Test System.

FDA Consensus Standards

Ldl & Vldl Precipitation, Hdl [11555]21 CFR §862.1475 🔎

Pre-market Notifications for LBR

K143691LDLC3 LDL-Cholesterol Gen.3Roche Diagnostics Operations (RDO)
K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSGENERAL ATOMICS
K050823DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATORTECO DIAGNOSTICS
K023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERHEMAGEN DIAGNOSTICS, INC.
K012593VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2Ortho-Clinical Diagnostics, Inc.
K992029ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSELAN DIAGNOSTICS
K992002AUTOHDL CHOLESTEROL REAGENT SETPOINTE SCIENTIFIC, INC.
K991789ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSELAN HOLDINGS, INC.
K990247MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470POLYMER TECHNOLOGY SYSTEMS, INC.
K984303VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENTOrtho-Clinical Diagnostics, Inc.
K980772HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51DIAGNOSTIC CHEMICALS LTD.
K980770HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51DIAGNOSTIC CHEMICALS LTD.
K974733BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROLBOEHRINGER MANNHEIM CORP.
K973369ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)ROCHE DIAGNOSTIC SYSTEMS, INC.
K971573N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SETGENZYME CORP.

Global Unique Device Identification Database

00381932702010LDL & VLDL PRECIPITATION, HDL
00381932700016LDL & VLDL PRECIPITATION, HDL
00381931821019LDL & VLDL PRECIPITATION, HDL
00381931788015LDL & VLDL PRECIPITATION, HDL
00381931714014LDL & VLDL PRECIPITATION, HDL
00381931709010LDL & VLDL PRECIPITATION, HDL
00380740129972LDL & VLDL PRECIPITATION, HDL
00628063400706LDL & VLDL PRECIPITATION, HDL
00628063400690LDL & VLDL PRECIPITATION, HDL
00628063400683LDL & VLDL PRECIPITATION, HDL
00628063400676LDL & VLDL PRECIPITATION, HDL
00628063400669LDL & VLDL PRECIPITATION, HDL
00657498000663Ldl & Vldl Precipitation, Hdl
00812137012074Ldl & Vldl Precipitation, Hdl
00811727015051Ldl & Vldl Precipitation, Hdl

Maude Adverse Events

LDLC3 LDL-CHOLESTEROL GEN.3ROCHE DIAGNOSTICS2019-08-07
LDLC3 LDL-CHOLESTEROL GEN.3ROCHE DIAGNOSTICS2019-08-05
COBAS INTEGRA 400 PLUSROCHE DIAGNOSTICS2017-10-02
LDL_C LDL-CHOLESTEROL PLUS 3ND GENERATIONROCHE DIAGNOSTICS2016-08-31
COBAS 6000 C501 MODULEROCHE DIAGNOSTICS2012-10-09
COBAS 6000 C501MODULEROCHE DIAGNOSTICS2011-03-17
PTS PANELS LIPID PANEL TEST STRIPSPOLYMER TECHNOLOGY SYSTEMS, INC.2008-12-16
VITROS CALIBRATOR KIT 2ORTHO-CLINICAL DIAGNOSTICS2007-07-26
VITROS CALIBRATOR KIT 2ORTHO-CLINICAL DIAGNOSTICS, INC.2003-06-24

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