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No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 08056771200097 316171 LIAISON® C-PEPTID
2 08056771100489 310351 LIAISON® Control Direct Renin
3 08056771100229 310211 LIAISON® Control HAV IgM
4 08056771102865 310502 LIAISON® EBV IgM Serum Control Set
5 08056771601788 310522 LIAISON® EBNA IgG Serum Control Set
6 08056771101752 310520 LIAISON® EBNA IgG
7 08056771100618 310480 LIAISON® Treponema Assay
8 08056771103671 311461 LIAISON® Control SARS-CoV-2 S1/S2 IgG
9 08056771103572 Q0001 NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis 3 LIAISON® QuantiFERON® Software
10 08056771103350 V619IMUS Biotrin Parvovirus B19 IgM EIA
11 08056771103343 V519IGUS Biotrin Parvovirus B19 IgG EIA
12 08056771103268 311020 NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis 3 LIAISON Quantiferon TB Gold Plus
13 08056771102988 310522 LIAISON® EBNA IgG Serum Control Set
14 08056771102872 MOL1001 LIAISON MDX
15 08056771102377 P001932 ETI-MAK-2 PLUS
16 08056771102360 P001931 ETI-AB-AUK PLUS
17 08056771102346 P001929 ETI-AB-EBK PLUS
18 08056771102148 I0050 LIAISON® XL
19 08056771101394 318841 LIAISON® Control Mumps IgG
20 08056771101325 318810 LIAISON® Measles IgG
21 08056771100809 310715 LIAISON® Toxo IgM II
22 08056771100779 310706 LIAISON® Control Toxo IgG II
23 08056771100762 310705 LIAISON® Toxo IgG II
24 08056771100496 310360 LIAISON® Insulin
25 08056771100212 310210 LIAISON® HAV IgM
26 08056771200356 389239 LIAISON® CONTROL THYROID 3
27 08056771200127 312171 LIAISON® Prolactin xt
28 08056771103442 318220 LIAISON® XL MUREX Anti-HBs
29 08056771103411 318151 LIAISON XL MUREX Control HBeAg
30 08056771102322 P001927 ETI-AB-COREK PLUS
31 08056771101905 310740 LIAISON® CMV IgG
32 E125N014308 N0143 HBsAg Confirmatory Test
33 08056771101387 318840 LIAISON® Mumps IgG
34 08056771100632 310496 LIAISON® Control VZV IgG
35 08056771100588 310461 LIAISON® Rubella IgG TRI-Controls
36 08056771200288 311531 LIAISON® FT3
37 08056771103381 318140 LIAISON XL MUREX HBcIgM
38 08056771101455 9450200 LIAISON Analyzer
39 08056771101127 310990 LIAISON® Cleaning kit
40 08056771100625 310495 LIAISON® VZV IgG
41 08056771100465 310341 LIAISON® Control hGH
42 08056771103428 318160 LIAISON XL MUREX Anti-HBe
43 08056771103039 318092 LIAISON BRAHMS PCT II GEN Verifiers
44 08056771102933 310742 LIAISON® CMV IgG Serum Control Set
45 08056771102889 MOL1011 LIAISON MDX
46 08056771102339 P001928 ETI-CORE-IGMK PLUS
47 08056771102315 P001926 ETI-AB-HAVK PLUS
48 08056771102308 P001925 ETI-HA-IGMK PLUS
49 08056771101950 310751 LIAISON® Control CMV IgM
50 08056771101875 310730 LIAISON® Rubella IgM
Other products with the same Product Code "QKO"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00682607200979 L031-11711 200979 Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25) ACON SARS-CoV-2 IgG/IgM Rapid Test ACON LABORATORIES, INC.
2 00630414607139 11417771 K7771 Vista COV2G Assay Vista COV2G Assay SIEMENS HEALTHCARE DIAGNOSTICS INC.
3 00630414607030 11417770 RF870 Dimension CV2G Assay Dimension CV2GAssay SIEMENS HEALTHCARE DIAGNOSTICS INC.
4 00630414605500 11417414 K7414 Vista COV2T Assay Vista COV2T Assay SIEMENS HEALTHCARE DIAGNOSTICS INC.
5 00630414605494 11417413 KC813 DV/DM COV2T/CV2T CAL DV/DM COV2T/CV2T CAL SIEMENS HEALTHCARE DIAGNOSTICS INC.
6 00630414605425 11417415 KC815 DV/DM COV2T/CV2T POS/NEG CTRL DV/DM COV2T/CV2T POS/NEG CTRL SIEMENS HEALTHCARE DIAGNOSTICS INC.
7 00630414605418 11417412 RF812 Dimension CV2T Assay Dimension CV2T Assay SIEMENS HEALTHCARE DIAGNOSTICS INC.
8 00380740193867 06S6130 06S6130 AdviseDx SARS-CoV-2 IgG II Reagent Kit 1000 Test Alinity ABBOTT IRELAND DIAGNOSTICS
9 00380740193843 06S6120 06S6120 AdviseDx SARS-CoV-2 IgG II Reagent Kit 200 Test Alinity ABBOTT IRELAND DIAGNOSTICS
10 00380740193829 06S6110 06S6110 AdviseDx SARS-CoV-2 IgG II Control Kit Alinity ABBOTT IRELAND DIAGNOSTICS
11 00380740193805 06S6101 06S6101 AdviseDx SARS-CoV-2 IgG II Calibrator Kit Alinity ABBOTT IRELAND DIAGNOSTICS
12 00380740193782 06S6030 06S6030 AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
13 00380740193768 06S6020 06S6020 AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
14 00380740193744 06S6010 06S6010 AdviseDx SARS-CoV-2 IgG II Control Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
15 00380740193720 06S6001 06S6001 AdviseDx SARS-CoV-2 IgG II Calibrator Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
16 00380740192167 06R8730 06R8730 AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
17 00380740192150 06R8630 06R8630 SARS-CoV-2 IgG Reagent Kit 500 Tests ARCHITECT ABBOTT LABORATORIES
18 00380740192136 06R9030 06R9030 SARS-CoV-2 IgG Reagent Kit 1000 Tests Alinity ABBOTT LABORATORIES
19 00380740192129 06R9020 06R9020 SARS-CoV-2 IgG Reagent Kit 200 Tests Alinity ABBOTT LABORATORIES
20 00380740192112 06R9010 06R9010 SARS-CoV-2 IgG Control Kit Alinity ABBOTT LABORATORIES
21 00380740192105 06R9001 06R9001 SARS-CoV-2 IgG Calibrator Kit Alinity ABBOTT LABORATORIES
22 00380740192099 06R9130 06R9130 AdviseDx SARS-CoV-2 IgM Reagent Kit 1000 Test Alinity ABBOTT IRELAND DIAGNOSTICS
23 00380740192082 06R9120 06R9120 AdviseDx SARS-CoV-2 IgM Reagent Kit 200 Test Alinity ABBOTT IRELAND DIAGNOSTICS
24 00380740192075 06R9110 06R9110 AdviseDx SARS-CoV-2 IgM Control Kit Alinity ABBOTT IRELAND DIAGNOSTICS
25 00380740192068 06R9101 06R9101 AdviseDx SARS-CoV-2 IgM Calibrator Kit Alinity ABBOTT IRELAND DIAGNOSTICS
26 00380740191863 06R8720 06R8720 AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
27 00380740191856 06R8710 06R8710 AdviseDx SARS-CoV-2 IgM Control Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
28 00380740191849 06R8701 06R8701 AdviseDx SARS-CoV-2 IgM Calibrator Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
29 00380740191832 06R8620 06R8620 SARS-CoV-2 IgG Reagent Kit 100 Tests ARCHITECT ABBOTT LABORATORIES
30 00380740191825 06R8610 06R8610 SARS-CoV-2 IgG Control Kit ARCHITECT ABBOTT LABORATORIES
31 00380740191818 06R8601 06R8601 SARS-CoV-2 IgG Calibrator Kit ARCHITECT ABBOTT LABORATORIES
32 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.
33 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.
34 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.
35 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.
36 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.
37 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.
38 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.
39 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.
40 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.
41 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.
42 10816467020386 SARS-CoV-2 IgG Immunoassay 25000085 90 Test Kit SARS-CoV-2 IgG Immunoassay FastPack SARS-CoV-2 IgG QUALIGEN INC.
43 10758750034581 6199976 6199976 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
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