PDJ

Product Code: PDJ


Products Classified as PDJ

653Hemoglobin A1c Test SystemHemoglobin A1c Test System.

Total Product Life Cycle (TPLC) Devices

653Hemoglobin A1c Test SystemHemoglobin A1c Test System.

Pre-market Notifications for PDJ

K200904Tosoh Automated Glycohemoglobin Analyzer HLC-723G8Tosoh Bioscience, Inc.
K200256ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc.
K193053Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics Operations (RDO)
K182988Afinion HbA1c Dx On Afinion 2Alere Technologies AS
K182651HbA1c AdvancedBeckman Coulter Ireland Inc.
K180296Afinion HbA1c DxAlere Technologies AS
K173909Dimension Hemoglobin A1c AssaySiemens Healthcare Diagnostics Inc.
K173206SEKURE HbA1c AssaySekisui Diagnostics PEI Inc.
K171861CAPILLARYS Hb A1cSebia
K171771ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics Inc.
K171537CAPI 3 Hb A1cSebia
K162822ADAMS A1c HA-8180V, CALIBRATOR 80Arkray Factory, Inc.
K161687D-10 Hemoglobin A1c ProgramBIO-RAD LABORATORIES, INC.
K160571Cobas C513 Analyzer, Cobas C13 Tina-quant HbA1cDx Gen.3 AssayRoche Diagnostics Operations (RDO)
K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc.

Global Unique Device Identification Database

00380740102746Hemoglobin A1c test system
00380740102739Hemoglobin A1c test system
00630414006659Hemoglobin A1c test system
00628063401147Hemoglobin A1c test system
00847817025693Hemoglobin A1c test system
00847817025679Hemoglobin A1c test system
00847817016035Hemoglobin A1c test system
00847817016028Hemoglobin A1c test system
07070060012889Hemoglobin A1c Test System
04987486015130Hemoglobin A1c Test System
14987486015120Hemoglobin A1c Test System
14987486015113Hemoglobin A1c Test System
14987486015106Hemoglobin A1c Test System
14987486015090Hemoglobin A1c Test System
04987486001973Hemoglobin A1c Test System

Maude Adverse Events

DIMENSION?SIEMENS HEALTHCARE DIAGNOSTICS INC2020-03-02
DIMENSION?SIEMENS HEALTHCARE DIAGNOSTICS INC2020-03-02
D-100 HBA1C, D-100? HBA1C CALIBRATOR PACKBIO-RAD LABORATORIES, INC.2017-05-19
COBAS INTEGRA (800) HBA1C DEDICATEDROCHE DIAGNOSTICS2015-07-20
ADVIA CHEMISTRY 2400 ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS INC.2015-03-31
ADVIA CHEMISTRY 2400 ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS INC.2015-03-31
DIMENSION RXL MAX WITH HMSIEMENS HEALTHCARE DIAGNOSTICS INC2014-11-17
DIMENSION EXL 200SIEMENS HEALTHCARE DIAGNOSTICS INC2014-11-17
DIMENSION EXL 200SIEMENS HEALTHCARE DIAGNOSTICS INC2014-11-14
COBAS 311ROCHE DIAGNOSTICS2014-10-10
COBAS INTEGRA (800) HBA1C DEDICATEDROCHE DIAGNOSTICS2014-09-04
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATORSIEMENS HEALTHCARE DIAGNOSTICS INC.2014-08-07
COBAS INTEGRA 800ROCHE DIAGNOSTICS2014-03-27
UNICEL? DXC 600 SYNCHRON? SYSTEMBECKMAN COULTER2014-02-12
UNICEL? DXC 600 SYNCHRON? SYSTEMBECKMAN COULTER2014-02-11
DCA VANTAGE ANALYZERSIMENS HEALTHCARE DIAGNOSTICS INC.2014-02-06
COBAS INTEGRA 800ROCHE DIAGNOSTICS2013-12-17
UNICEL? DXC 600 SYNCHRON? SYSTEMBECKMAN COULTER2013-11-27
COBAS INTEGRA 800ROCHE DIAGNOSTICS2013-10-30
ADVIA 1800SIEMENS HEALTHCARE DIAGNOSTICS INC.2013-10-21
COBAS INTEGRA 400 PLUSROCHE DIAGNOSTICS2013-09-19
COBAS INTEGRA 800ROCHE DIAGNOSTICS2013-08-26
DIMENSION? XPAND PLUS WITH HMSIEMENS HEALTHCARE DIAGNOSTICS INC2013-06-21
UNICEL? DXC 800 PRO SYNCHRON? ACCESS? CLINICAL SYSTEMBECKMAN COULTER2013-05-29
ADVIA 1800SIEMENS HEALTHCARE DIAGNOSTICS INC.2013-05-29
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