Other products from "ABBOTT IRELAND DIAGNOSTICS"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00380740193867 06S6130 06S6130 AdviseDx SARS-CoV-2 IgG II Reagent Kit 1000 Test QKO Reagent, coronavirus serological Alinity
2 00380740193843 06S6120 06S6120 AdviseDx SARS-CoV-2 IgG II Reagent Kit 200 Test QKO Reagent, coronavirus serological Alinity
3 00380740193829 06S6110 06S6110 AdviseDx SARS-CoV-2 IgG II Control Kit QKO Reagent, coronavirus serological Alinity
4 00380740193805 06S6101 06S6101 AdviseDx SARS-CoV-2 IgG II Calibrator Kit QKO Reagent, coronavirus serological Alinity
5 00380740193782 06S6030 06S6030 AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test QKO Reagent, coronavirus serological ARCHITECT
6 00380740193768 06S6020 06S6020 AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test QKO Reagent, coronavirus serological ARCHITECT
7 00380740112424 07K68-35 07K6835 ARCHITECT CEA Reagent kit DHX SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN 2 ARCHITECT
8 00380740112400 3P36-35 03P3635 ARCHITECT AFP Reagent Kit LOK KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS 3 ARCHITECT
9 00380740105433 1L82-36 01L8236 ARCHITECT AUSAB Reagent LOM Test, hepatitis b (b core, be antigen, be antibody, b core igm) 3 ARCHITECT
10 00380740105426 1L82-26 01L8226 ARCHITECT AUSAB Reagent LOM Test, hepatitis b (b core, be antigen, be antibody, b core igm) 3 ARCHITECT
11 00380740105419 1L82-13 01L8213 ARCHITECT AUSAB Controls LOM Test, hepatitis b (b core, be antigen, be antibody, b core igm) 3 ARCHITECT
12 00380740105402 1L82-03 01L8203 ARCHITECT AUSAB Calibrators LOM Test, hepatitis b (b core, be antigen, be antibody, b core igm) 3 ARCHITECT
13 00380740081317 3P36-25 03P3625 ARCHITECT AFP Reagent Kit LOK KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS 3 ARCHITECT
14 00380740081294 3P36-10 03P3610 ARCHITECT AFP Controls LOK KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS 3 ARCHITECT
15 00380740081287 3P36-01 03P3601 ARCHITECT AFP Calibrators LOK KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS 3 ARCHITECT
16 00380740014582 07K68-32 07K6832 ARCHITECT CEA Reagent kit DHX SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN 2 ARCHITECT
17 00380740014575 07K68-27 07K6827 ARCHTECT CEA Reagent kit DHX SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN 2 ARCHITECT
18 00380740014551 07K68-12 07K6812 ARCHITECT CEA Controls DHX SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN 2 ARCHITECT
19 00380740014544 07K68-02 07K6802 ARCHITECT CEA Calibrators DHX SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN 2 ARCHITECT
20 00380740013066 7D82-50 07D8250 ARCHITECT Multi -Assay Manual Diluent JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 1 ARCHITECT
21 00380740009786 06E2365 06E2365 ARCHITECT PRE TRIGGER SOLUTION JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 1 ARCHITECT
22 00380740009625 6C55-60 06C5560 ARCHITECT TRIGGER SOLUTION JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 1 ARCHITECT
23 00380740009618 6C54-88 06C5488 ARCHITECT CONCENTRATED WASH BUFFER (10L) JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 1 ARCHITECT
24 00380740009601 6C54-58 06C5458 ARCHITECT CONCENTRATED WASH BUFFER JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 1 ARCHITECT
25 00380740009021 6C07-27 06C0727 ARCHITECT Free PSA Reagent Kit MTG TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCE TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS 3 ARCHITECT
26 00380740009014 6C07-10 06C0710 ARCHITECT Free PSA Controls MTG TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCE TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS 3 ARCHITECT
27 00380740009007 6C07-01 06C0701 ARCHITECT Free PSA Calibrators MTG TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCE TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS 3 ARCHITECT
28 00380740008994 6C06-35 06C0635 ARCHITECT Total PSA Reagent Kit JJX,JJE,JIS,LTJ,MTF SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),ANALYZER, CHEMISTRY SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,CALIBRATOR, PRIMARY,PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS,TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER 1 ARCHITECT
29 00380740008987 6C06-27 06C0627 ARCHITECT Total PSA Reagent Kit LTJ,JJX,JIS,JJE,MTF PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS,SINGLE (SPECI PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS,SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),CALIBRATOR, PRIMARY,ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER 1 ARCHITECT
30 00380740193720 06S6001 06S6001 AdviseDx SARS-CoV-2 IgG II Calibrator Kit QKO Reagent, coronavirus serological ARCHITECT
31 00380740192167 06R8730 06R8730 AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test QKO Reagent, coronavirus serological ARCHITECT
32 00380740192099 06R9130 06R9130 AdviseDx SARS-CoV-2 IgM Reagent Kit 1000 Test QKO Reagent, coronavirus serological Alinity
33 00380740192082 06R9120 06R9120 AdviseDx SARS-CoV-2 IgM Reagent Kit 200 Test QKO Reagent, coronavirus serological Alinity
34 00380740192075 06R9110 06R9110 AdviseDx SARS-CoV-2 IgM Control Kit QKO Reagent, coronavirus serological Alinity
35 00380740192068 06R9101 06R9101 AdviseDx SARS-CoV-2 IgM Calibrator Kit QKO Reagent, coronavirus serological Alinity
36 00380740191863 06R8720 06R8720 AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test QKO Reagent, coronavirus serological ARCHITECT
37 00380740191856 06R8710 06R8710 AdviseDx SARS-CoV-2 IgM Control Kit QKO Reagent, coronavirus serological ARCHITECT
38 00380740191849 06R8701 06R8701 AdviseDx SARS-CoV-2 IgM Calibrator Kit QKO Reagent, coronavirus serological ARCHITECT
39 00380740174941 04V3831 04V3831 Alinity i STAT CK-MB Reagent Kit 1000 Tests JHX FLUOROMETRIC METHOD, CPK OR ISOENZYMES 2 Alinity
40 00380740174927 04V3821 04V3821 Alinity i STAT CK-MB Reagent Kit 200 Tests JHX FLUOROMETRIC METHOD, CPK OR ISOENZYMES 2 Alinity
41 00380740174910 04V3730 04V3730 Alinity i STAT Myoglobin Reagent Kit 1000 Tests DDR MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL 2 Alinity
42 00380740174903 04V3720 04V3720 Alinity i STAT Myoglobin Reagent Kit 200 Tests DDR MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL 2 Alinity
43 00380740172282 04V3710 04V3710 Alinity i STAT Myoglobin Controls JJY Multi-analyte controls, all kinds (assayed) 1 Alinity
44 00380740172275 04V3701 04V3701 Alinity i STAT Myoglobin Calibrators JIS Calibrator, primary 2 Alinity
45 00380740165505 04V3810 04V3810 Alinity i STAT CK-MB Controls JJY Multi-analyte controls, all kinds (assayed) 1 Alinity
46 00380740165482 04V3801 04V3801 Alinity i STAT CK-MB Calibrators JIS Calibrator, primary 2 Alinity
47 00380740158347 07P9331 07P9331 Alinity i Free PSA Reagent Kit 1000 Tests MTG Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate ca Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions 3 Alinity
48 00380740158330 07P9321 07P9321 Alinity i Free PSA Reagent Kit 200 Tests MTG Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate ca Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions 3 Alinity
49 00380740158323 07P9231 07P9231 Alinity i Total PSA Reagent Kit 1200 Tests MTF Total, prostate specific antigen (noncomplexed & complexed) for detection of pro Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer 3 Alinity
50 00380740158316 07P9221 07P9221 Alinity i Total PSA Reagent Kit 200 Tests MTF Total, prostate specific antigen (noncomplexed & complexed) for detection of pro Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer 3 Alinity
Other products with the same Product Code "QKO"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 M90171108B0 71108B 71108B QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one s QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus. QuickProfile™ 2019-nCoV IgG/IgM Antibody Test LUMIQUICK DIAGNOSTICS, INC.
2 15099590742768 C69059 C69059 The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG II assay using the Access Immunoassay Systems only.The Access SARS-CoV-2 IgG II QC are only for use under the Food and Drug Administration's Emergency Use Authorization. Access SARS-CoV-2 IgG II QC BECKMAN COULTER, INC.
3 15099590742751 C69058 C69058 The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SA The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Immunoassay Systems only.The Access SARS-CoV-2 IgG II calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization. Access SARS-CoV-2 IgG II Calibrator BECKMAN COULTER, INC.
4 15099590742744 C69057 C69057 The Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent The Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent immunoassay intended for the semi-quantitative and qualitative detection of IgG antibodies to SARS-CoV-2 in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). The Access SARS-CoV-2 IgG II assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Access SARS-CoV-2 IgG II should not be used to diagnose or exclude acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.The Access SARS-CoV-2 IgG II assay is only for use under the Food and Drug Administration's Emergency Use Authorization. Access SARS-CoV-2 IgG II BECKMAN COULTER, INC.
5 15099590738662 C58964 C58964 The Access SARS-CoV-2 IgG QC is intended for monitoring system performance of th The Access SARS-CoV-2 IgG QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG assay. The Access SARS-CoV-2 IgG QC is for use on the Access Family of Immunoassay Systems only.The Access SARS-CoV-2 IgG QC are only for use under the Food and Drug Administration's Emergency Use Authorization. Access SARS-CoV-2 IgG QC BECKMAN COULTER, INC.
6 15099590738655 C58963 C58963 The Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS- The Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS-CoV-2 IgG assay for the in vitro qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG Calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization. Access SARS-CoV-2 IgG Calibrator BECKMAN COULTER, INC.
7 15099590738648 C58961 C58961 The Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent imm The Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). The Access SARS-CoV-2 IgG assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.The Access SARS-CoV-2 IgG assay is only for use under the Food and Drug Administration's Emergency Use Authorization. Access SARS-CoV-2 IgG BECKMAN COULTER, INC.
8 15099590738631 C58959 C58959 The Access SARS-CoV-2 IgM QC is intended for monitoring system performance of th The Access SARS-CoV-2 IgM QC is intended for monitoring system performance of the Access SARS-CoV-2 IgM assay. The Access SARS-CoV-2 IgM QC is for use on the Access Family of Immunoassay Systems only.The Access SARS-CoV-2 IgM QC are only for use under the Food and Drug Administration's Emergency Use Authorization. Access SARS-CoV-2 IgM QC BECKMAN COULTER, INC.
9 15099590738624 C58958 C58958 The Access SARS-CoV-2 IgM Calibrators are intended to calibrate the Access SARS- The Access SARS-CoV-2 IgM Calibrators are intended to calibrate the Access SARS-CoV-2 IgM assay for the in vitro qualitative detection of SARS-CoV-2 IgM antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate) for use on the Access Family of Immunoassay Systems only.The Access SARS-CoV-2 IgM calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization. Access SARS-CoV-2 IgM Calibrator BECKMAN COULTER, INC.
10 15099590738617 C58957 C58957 The Access SARS-CoV-2 IgM is a paramagnetic particle, chemiluminescent immunoass The Access SARS-CoV-2 IgM is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate). The Access SARS-CoV-2 IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Access SARS-CoV-2 IgM should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.The Access SARS-CoV-2 IgM assay is only for use under the Food and Drug Administration's Emergency Use Authorization. Access SARS-CoV-2 IgM BECKMAN COULTER, INC.
11 10816467020386 SARS-CoV-2 IgG Immunoassay 25000085 90 Test Kit SARS-CoV-2 IgG Immunoassay FastPack SARS-CoV-2 IgG QUALIGEN INC.
12 10758750034581 6199976 6199976 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
13 10758750034567 6199975 6199975 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
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22 10722066005115 COV-13C25 COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) Rapid Response BTNX INC
23 08809317540924 FREND COVID-19 total Ab FRCOA 020 The COVID-19 total Ab is designed for the qualitative and quantitative measureme The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA,and citrate) by fluorescence immunoassay (FIA) using the FREND™ System. FREND NANOENTEK, INC.
24 08809317540917 COVID-19 total Ab Control LQ FIC-COALQ The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COV The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COVID-19 total Ab cartridges. COVID-19 total Ab Control LQ is not intended for use as a standard. FREND NANOENTEK, INC.
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42 00380740193867 06S6130 06S6130 AdviseDx SARS-CoV-2 IgG II Reagent Kit 1000 Test Alinity ABBOTT IRELAND DIAGNOSTICS
43 00380740193843 06S6120 06S6120 AdviseDx SARS-CoV-2 IgG II Reagent Kit 200 Test Alinity ABBOTT IRELAND DIAGNOSTICS
44 00380740193829 06S6110 06S6110 AdviseDx SARS-CoV-2 IgG II Control Kit Alinity ABBOTT IRELAND DIAGNOSTICS
45 00380740193805 06S6101 06S6101 AdviseDx SARS-CoV-2 IgG II Calibrator Kit Alinity ABBOTT IRELAND DIAGNOSTICS
46 00380740193782 06S6030 06S6030 AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
47 00380740193768 06S6020 06S6020 AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
48 00380740193744 06S6010 06S6010 AdviseDx SARS-CoV-2 IgG II Control Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
49 00380740193720 06S6001 06S6001 AdviseDx SARS-CoV-2 IgG II Calibrator Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
50 00380740192167 06R8730 06R8730 AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS