JFM

Product Code: JFM


Products Classified as JFM

384Enzymatic Method, BilirubinBilirubin (total Or Direct) Test System.

Total Product Life Cycle (TPLC) Devices

384Enzymatic Method, BilirubinBilirubin (total Or Direct) Test System.

Pre-market Notifications for JFM

K170065ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc.
K152344Total BilirubinRANDOX LABORATORIES LIMITED
K152343Direct BilirubinRANDOX LABORATORIES LIMITED
K063845ADVIA CHEMISTRY TOTAL BILIRUBIN_2BAYER HEALTHCARE, LLC
K053132WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791WAKO CHEMICALS, USA, INC.
K053131WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191WAKO CHEMICALS, USA, INC.
K053090DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATORBECKMAN COULTER, INC.
K050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORSTANBIO LABORATORY
K970985WAKO TOTAL BILIRUBIN VWAKO CHEMICALS, USA, INC.
K904660ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14DIAGNOSTIC CHEMICALS, LTD. (USA)
K843174DRI-STAT ENZYMATIC BILIRUBIN TEST KITBECKMAN INSTRUMENTS, INC.

Global Unique Device Identification Database

00630414595818ENZYMATIC METHOD, BILIRUBIN
00630414595801ENZYMATIC METHOD, BILIRUBIN
00630414513089ENZYMATIC METHOD, BILIRUBIN
00630414513072ENZYMATIC METHOD, BILIRUBIN
00630414513065ENZYMATIC METHOD, BILIRUBIN
00657498001493Enzymatic Method, Bilirubin
00657498001486Enzymatic Method, Bilirubin
00657498000588Enzymatic Method, Bilirubin
00657498000564Enzymatic Method, Bilirubin
05055273208337Enzymatic Method, Bilirubin
05055273208320Enzymatic Method, Bilirubin
05055273208313Enzymatic Method, Bilirubin
05055273208306Enzymatic Method, Bilirubin
15099590222642Enzymatic Method, Bilirubin
05055273214796Enzymatic Method, Bilirubin

Maude Adverse Events

ARCHITECT C16000 SYSTEMABBOTT MANUFACTURING INC2016-05-03
ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENTSIEMENS HEALTHCARE DIAGNOSTICS INC.2015-09-04
ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENTSIEMENS HEALTHCARE DIAGNOSTICS INC.2015-08-28
UNICEL? DXC 600 SYNCHRON? SYSTEMBECKMAN COULTER, INC.2012-03-28
UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZERBECKMAN COULTER, INC.2011-08-07
UNICEL? DXC 600I SYNCHRON? ACCESS? CLINICAL SYSTEMBECKMAN COULTER, INC.2011-08-03
UNICEL? DXC 600I SYNCHRON? ACCESS? CLINICAL SYSTEMBECKMAN COULTER, INC.2011-08-03
CX/LX DBIL KITBECKMAN COULTER INC.2011-06-21
CX/LX DBIL KITBECKMAN COULTER INC.2011-06-17
CX/LX DBIL KITBECKMAN COULTER INC.2011-01-04
UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZERBECKMAN COULTER, INC.2010-11-27
UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZERBECKMAN COULTER, INC.2010-11-27
UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZERBECKMAN COULTER, INC.2010-11-27
NOT APPLICABLEBECKMAN COULTER INC.2010-11-22
COBAS INTEGRA 800ROCHE DIAGNOSTICS2010-07-14
COBAS 6000 C501 MODULEROCHE DIAGNOSTICS2010-04-30
ANALYTICAL P MODULEROCHE DIAGNOSTICS2010-03-16
CLINICAL CHEMISTRY BILIRUBIN CALIBRATORABBOTT MFG INC.2008-10-17
CLINICAL CHEMISTRY BILIRUBIN CALIBRATORABBOTT MANUFACTURING INC2008-10-17
ABBOTT CLINICAL CHEMISTRY TOTAL BILIRUBINABBOTT MANUFACTURING, INC.2007-10-11
ABBOTT CLINICAL CHEMISTRY TOTAL BILIRUBINABBOTT MANUFACTURING, INC.2007-10-11
ABBOTT CLINICAL CHEMISTRY TOTAL BILIRUBINABBOTT MANUFACTURING, INC.2007-10-11
ABBOTT CLINICAL CHEMISTRY TOTAL BILIRUBINABBOTT MANUFACTURING, INC.2007-10-11
ABBOTT CLINICAL CHEMISTRY TOTAL BILIRUBINABBOTT MANUFACTURING INC.2007-10-11
CLINICAL CHEMISTRY BILIRUBIN CALIBRATORABBOTT MANUFACTURING, INC.2007-09-06
CLINICAL CHEMISTRY BILIRUBIN CALIBRATORABBOTT MANUFACTURING, INC.2007-09-05
CLINICAL CHEMISTRY BILIRUBIN CALIBRATORABBOTT MANUFACTURING, INC.2007-09-05
DADE DIMENSION ARDADE BEHRING,INC.1999-11-16

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