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Panels › Immunology › Product code NIG · Class 2

System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

Regulation 866.6010

1510(k)s in 12 months (12 all time)
0recalls in 12 months (19 all time)
14recalls that name a 510(k)
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Top companies in NIG

DateFirm and productCodeLinked 510(k)
Sep 11, 2024Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10
Open, Classified
NIGK031393
Sep 11, 2024Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 1049
Open, Classified
NIGK031393
Sep 11, 2024Siemens Healthcare Diagnostics, Inc.
Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SM
Open, Classified
NIGK031393
Sep 11, 2024Siemens Healthcare Diagnostics, Inc.
Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN:109
Open, Classified
NIGK031393
Sep 11, 2024Siemens Healthcare Diagnostics, Inc.
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 109954
Open, Classified
NIGK031393
Jun 2, 2020Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniC
Terminated
NIGK033038
Mar 5, 2020Roche Diagnostics Operations, Inc.
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Terminated
NIGK050231
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
Terminated
NIGK023240
May 9, 2017Beckman Coulter Inc.
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Terminated
NIGK033038
Oct 19, 2016Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491244 In the 510(k) d
Terminated
NIGK031393
Oct 19, 2016Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) d
Terminated
NIGK031393
Aug 11, 2014ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS CA 19-9 Reagent Packs are used on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System
Terminated
NIGNone listed
Dec 11, 2012Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tu
Terminated
NIGK031393
Jun 29, 2012Abbott Laboratories
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent
Terminated
NIGK052000
Jan 11, 2012Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA19-9 Assay Cat. Nos. 123521 (03481938) - 250 Test kit w/o Calibrators 123519 (04612750) - 50 Test kit w/o Calibrators 10491244 - 250 Test kit w/Calibrators 10491379 - 50 Test kit w/Cal
Terminated
NIGNone listed
Mar 11, 2011BioCheck Inc
CA19-9 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Terminated
NIGNone listed
Nov 30, 2004Tosoh Bioscience, Inc.
TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media
Terminated
NIGK971103
Nov 16, 2004Tosoh Bioscience, Inc.
Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays of 20 test cups, Catalog #: 020271, For IN VITRO Diagnostic Use, The product is manufactured
Terminated
NIGNone listed
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A.
Terminated
NIGNone listed

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