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)
Top companies in NIG
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2024 | Siemens 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 |
NIG | K031393 |
| Sep 11, 2024 | Siemens 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 |
NIG | K031393 |
| Sep 11, 2024 | Siemens 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 |
NIG | K031393 |
| Sep 11, 2024 | Siemens 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 |
NIG | K031393 |
| Sep 11, 2024 | Siemens 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 |
NIG | K031393 |
| Jun 2, 2020 | Beckman 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 |
NIG | K033038 |
| Mar 5, 2020 | Roche 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 |
NIG | K050231 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK CA 19-9; Part Number: 025271
Assay, Tumor Marker Terminated |
NIG | K023240 |
| May 9, 2017 | Beckman Coulter Inc. Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687 Terminated |
NIG | K033038 |
| Oct 19, 2016 | Siemens 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 |
NIG | K031393 |
| Oct 19, 2016 | Siemens 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 |
NIG | K031393 |
| Aug 11, 2014 | ORTHO-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 |
NIG | None listed |
| Dec 11, 2012 | Siemens 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 |
NIG | K031393 |
| Jun 29, 2012 | Abbott 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 |
NIG | K052000 |
| Jan 11, 2012 | Siemens 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 |
NIG | None listed |
| Mar 11, 2011 | BioCheck Inc CA19-9 ELISA Kit.
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
NIG | None listed |
| Nov 30, 2004 | Tosoh Bioscience, Inc. TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media Terminated |
NIG | K971103 |
| Nov 16, 2004 | Tosoh 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 |
NIG | None listed |
| Jul 20, 2004 | Abbott 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 |
NIG | None listed |
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