NIG

Product Code: NIG


Products Classified as NIG

3062System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic CancerTumor-associated Antigen Immunological Test System.

Total Product Life Cycle (TPLC) Devices

3062System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic CancerTumor-associated Antigen Immunological Test System.

Pre-market Notifications for NIG

K200997Lumipulse G CA19-9-NFujirebio Diagnostics, Inc.
K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc.
K100375DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604Siemens Healthcare Diagnostics Inc.
K052889VITROS CA 19-9FUJIREBIO DIAGNOSTICS, INC.
K052000ARCHITECT CA 19-9XR ASSAYFUJIREBIO DIAGNOSTICS, INC.
K033038GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688BECKMAN COULTER, INC.
K031393BAYER ADVIA CENTAUR CA 19-9 ASSAYBAYER HEALTHCARE, LLC
K023240ST AIA-PACK CA 19-9TOSOH CORP.
K023239AIA-PACK CA 19-9TOSOH CORP.
K020566FUJIREBIO DIAGNOSTICS CA 19-9 RIAFUJIREBIO DIAGNOSTICS, INC.

Global Unique Device Identification Database

00380740155919SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
00380740145408SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
00380740145392SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
00380740003562SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
00630414598192SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
00630414598185SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
00630414598178SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
00630414598161SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
00630414577135SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
00630414577128SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
00630414574257SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
00630414574028SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
00630414447926SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
00842768028533SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
04560189211124System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

Maude Adverse Events

ALINITY I CA 19-9XRABBOTT GMBH2020-03-25
ALINITY I CA 19-9XRABBOTT GMBH2020-03-23
ADVIA CENTAUR XP CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-27
ADVIA CENTAUR XP CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-27
ADVIA CENTAUR XP CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-27
ADVIA CENTAUR XP CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-27
ADVIA CENTAUR XP CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-27
CA 19-9 ELECSYS E2GROCHE DIAGNOSTICS2020-02-19
CA 19-9 ELECSYS E2GROCHE DIAGNOSTICS2020-02-18
CA 19-9 ELECSYS E2GROCHE DIAGNOSTICS2020-02-13
CA 19-9 ELECSYS E2GROCHE DIAGNOSTICS2020-02-03
CA 19-9 ELECSYS E2GROCHE DIAGNOSTICS2020-01-23
ADVIA CENTAUR XP CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-01-21
ADVIA CENTAUR XP CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-01-21
ARCHITECT CA 19-9XRABBOTT GMBH2020-01-15
ARCHITECT CA 19-9XRABBOTT GMBH2020-01-15
CA 19-9 ELECSYS E2GROCHE DIAGNOSTICS2020-01-10
ALINITY I CA 19-9XRABBOTT GMBH2020-01-09
ARCHITECT CA 19-9XRABBOTT GMBH2020-01-08
CA 19-9 ELECSYS E2GROCHE DIAGNOSTICS2020-01-07
COBAS 8000 E 801 MODULEROCHE DIAGNOSTICS2020-01-06
ADVIA CENTAUR XP CA 19-9 IMMUNOASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-01-06
ARCHITECT CA 19-9XRABBOTT GMBH2020-01-06
ARCHITECT CA 19-9XRABBOTT GMBH2019-12-27
CA 19-9 ELECSYS E2GROCHE DIAGNOSTICS2019-12-06
CA 19-9 ELECSYS E2GROCHE DIAGNOSTICS2019-11-27
ADVIA CENTAUR XPT CA19-9SIEMENS HEALTHCARE DIAGNOTICS, INC2019-11-26
ADVIA CENTAUR XPT CA19-9SIEMENS HEALTHCARE DIAGNOTICS, INC2019-11-26
ADVIA CENTAUR XPT CA19-9SIEMENS HEALTHCARE DIAGNOTICS, INC2019-11-26
ALINITY I CA 19-9XRABBOTT GERMANY2019-11-26
ADVIA CENTAUR XPT CA19-9SIEMENS HEALTHCARE DIAGNOTICS, INC2019-11-26
CA 19-9 ELECSYS E2GROCHE DIAGNOSTICS2019-11-22
CA 19-9 ELECSYS E2GROCHE DIAGNOSTICS2019-11-22
ATELLICA IM ANALYZER CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-11-20
ATELLICA IM ANALYZER CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-11-20
ADVIA CENTAUR XP CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-11-20
ADVIA CENTAUR XPT CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-11-20
ADVIA CENTAUR XPT CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-11-20
ARCHITECT CA 19-9XRABBOTT GERMANY2019-11-15
ARCHITECT CA 19-9XRABBOTT GERMANY2019-11-15
CA 19-9 ELECSYS E2GROCHE DIAGNOSTICS2019-11-15
ADVIA CENTAUR CP CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-11-13
ADVIA CENTAUR CP CA 19-9SIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-11-13
ALINITY I CA 19-9XRABBOTT GERMANY2019-11-07
ARCHITECT CA 19-9XRABBOTT GERMANY2019-11-06
ARCHITECT CA 19-9XRABBOTT GERMANY2019-10-31
ARCHITECT CA 19-9XRABBOTT GERMANY2019-10-28
ALINITY I CA 19-9XRABBOTT GERMANY2019-10-23
ARCHITECT CA 19-9XRABBOTT GERMANY2019-10-21
ARCHITECT CA 19-9XRABBOTT GERMANY2019-10-18
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