DFC

Product Code: DFC


Products Classified as DFC

2967Lipoprotein, Low-density, Antigen, Antiserum, ControlLow-density Lipoprotein Immunological Test System.

Total Product Life Cycle (TPLC) Devices

2967Lipoprotein, Low-density, Antigen, Antiserum, ControlLow-density Lipoprotein Immunological Test System.

FDA Consensus Standards

Lipoprotein, Low-Density, Antigen, Antiserum, Control [32366]21 CFR §866.5600 🔎

Pre-market Notifications for DFC

K180074Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc.
K123046ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATORSiemens Healthcare Diagnostics Inc.
K122722COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160Roche Diagnostics
K082488DIAZYME LP(A) ASSAYGENERAL ATOMICS
K063838LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGHTHERMO ELECTRON OY
K050487QUANTIA LA(A)BIOKIT S.A.
K023853K-ASSAY LP(A) CONTROLSKAMIYA BIOMEDICAL CO.
K021660K-ASSAY LP(A) ASSAYKAMIYA BIOMEDICAL CO.
K013359LP(A)-LATEX SEIKEN ASSAY KITDENKA SEIKEN'S
K013207TINA-QUANT APOLIPOPROTEIN B VER.2ROCHE DIAGNOSTICS CORP.
K013206TINA-QUANT APOLIPOPROTEIN B VER.2ROCHE DIAGNOSTICS CORP.
K013128N LATEX LP(A)DADE BEHRING, INC.
K001931WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSETWAKO CHEMICALS, USA, INC.
K001934WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CXWAKO CHEMICALS, USA, INC.
K001933WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIOWAKO CHEMICALS, USA, INC.

Global Unique Device Identification Database

00380740054267LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL
00380740019723LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL
00630414595559LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL
M204502001AA0Lipoprotein, Low-Density, Antigen, Antiserum, Control
00811727011831Lipoprotein, Low-Density, Antigen, Antiserum, Control
00811727011824Lipoprotein, Low-Density, Antigen, Antiserum, Control
00817439021090Lipoprotein, Low-Density, Antigen, Antiserum, Control
00817439021069Lipoprotein, Low-Density, Antigen, Antiserum, Control
00817302020151LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL
00817302020144LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL
00817302020137LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL
00816426020979Lipoprotein, Low-Density, Antigen, Antiserum, Control
00816426020962Lipoprotein, Low-Density, Antigen, Antiserum, Control
00816426020245Lipoprotein, Low-Density, Antigen, Antiserum, Control
00816426020122Lipoprotein, Low-Density, Antigen, Antiserum, Control

Maude Adverse Events

APO B VER.2 TINA-QUANT APOLIPOPROTEIN B VER.2ROCHE DIAGNOSTICS2016-11-08
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