Other products from "ORTHO CLINICAL DIAGNOSTICS"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 10758750034895 6177750 6177750 VITROS Immunodiagnostic ProductsAFP Calibrators JIS Calibrator, primary 2 VITROS
2 10758750034819 6177745 6177745 VITROS Immunodiagnostic Products AFP Reagent Pack LOJ KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER 2 VITROS
3 10758750034659 6199330 6199330 VITROS Immunodiagnostic ProductsProlactin Calibrators JIS Calibrator, primary 2 VITROS
4 10758750034420 6199961 6199961 VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator QKO Reagent, coronavirus serological VITROS
5 10758750034413 6199960 6199960 VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack QKO Reagent, coronavirus serological VITROS
6 10758750034321 6199337 6199337 VITROS Immunodiagnostic Products Prolactin Reagent Pack CFT RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) 1 VITROS
7 10758750034314 6199336 6199336 VITROS Immunodiagnostic Products CK-MB Reagent Pack JHX FLUOROMETRIC METHOD, CPK OR ISOENZYMES 2 VITROS
8 10758750033409 6199924 6199924 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls QKO Reagent, coronavirus serological VITROS
9 10758750033393 6199923 6199923 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator QKO Reagent, coronavirus serological VITROS
10 10758750033386 6199922 6199922 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack QKO Reagent, coronavirus serological VITROS
11 10758750033379 6199921 6199921 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls QKO Reagent, coronavirus serological VITROS
12 10758750033355 6199919 6199919 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack QKO Reagent, coronavirus serological VITROS
13 10758750033317 6192256 6192256 VITROS Immunodiagnostic Products NT-proBNP II Calibrators JIT Calibrator, secondary 2 VITROS
14 10758750033300 6192255 6192255 VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack NBC Test, natriuretic peptide 2 VITROS
15 10758750033294 6195575 6195575 VITROS Immunodiagnostic Products BRAHMS PCT Calibrator PMT Device to detect and measure procalcitonin (PCT) in human clinical specimens 2 VITROS
16 10758750033287 6197735 6197735 VITROS Immunodiagnostic Products BRAHMS PCT Reagent Pack PMT Device to detect and measure procalcitonin (PCT) in human clinical specimens 2 VITROS
17 10758750033195 691 2265 691 2265 VITROS Immunodiagnostic Products HIV Combo Controls (Anti-HIV-1 group O) OHQ Multi-analyte controls unassayed 1 VITROS
18 10758750033171 691 2263 691 2263 VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen) OHQ Multi-analyte controls unassayed 1 VITROS
19 10758750033164 691 2261 691 2261 VITROS Immunodiagnostic Products HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2) OHQ Multi-analyte controls unassayed 1 VITROS
20 10758750032945 6905561 6905561 VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers PMT Device to detect and measure procalcitonin (PCT) in human clinical specimens 2 VITROS
21 10758750032938 6905560 6905560 VITROS Immunodiagnostic Products BRAHMS PCT Controls PMT Device to detect and measure procalcitonin (PCT) in human clinical specimens 2 VITROS
22 10758750032068 6844425 6844425 VITROS Immunodiagnostic Products Insulin Reagent Pack CFP RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN 1 VITROS
23 10758750032051 6844424 6844424 VITROS Immunodiagnostic Products C-peptide Calibrators JIT Calibrator, secondary 2 VITROS
24 10758750032044 6844426 6844426 VITROS Immunodiagnostic Products Insulin Calibrators JIT Calibrator, secondary 2 VITROS
25 10758750032037 6844423 6844423 VITROS Immunodiagnostic Products C-peptide Reagent Pack JKD RADIOIMMUNOASSAY, C-PEPTIDES OF PROINSULIN 1 VITROS
26 10758750031597 6842782 6842782 VITROS Immunodiagnostic Products HIV Combo Calibrator MZF Test, hiv detection 2 VITROS
27 10758750031580 6842781 6842781 VITROS Immunodiagnostic Products HIV Combo Reagent Pack MZF Test, hiv detection 2 VITROS
28 10758750030217 6844056 6844056 VITROS Immunodiagnostic Products25-OH Vitamin D Total Reagent Pack MRG SYSTEM, TEST, VITAMIN D 2 VITROS
29 10758750030200 6844055 6844055 VITROS Immunodiagnostic Products25-OH Vitamin D Total Calibrators JIT CALIBRATOR, SECONDARY 2 VITROS
30 10758750009541 1681543 1681543 VITROS Immunodiagnostic Products Cortisol Calibrators JIS CALIBRATOR, PRIMARY 2 VITROS
31 10758750009411 1619360 1619360 VITROS Immunodiagnostic Products Anemia Controls JJY Multi-analyte controls, all kinds (assayed) 1 VITROS
32 10758750009404 1614965 1614965 VITROS Immunodiagnostic Products Total T3 Calibrators JIS CALIBRATOR, PRIMARY 2 VITROS
33 10758750009367 1540525 1540525 VITROS Immunodiagnostic Products Vitamin B12 Calibrators CDD RADIOASSAY, VITAMIN B12 2 VITROS
34 10758750009237 1513266 1513266 VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 CGN ACID, FOLIC, RADIOIMMUNOASSAY 2 VITROS
35 10758750009213 1487289 1487289 VITROS Immunodiagnostic Products TSH Calibrators JIT CALIBRATOR, SECONDARY 2 VITROS
36 10758750009145 1471481 1471481 VITROS Immunodiagnostic Products T3 Uptake Reagent Pack KHQ RADIOASSAY, TRIIODOTHYRONINE UPTAKE 2 VITROS
37 10758750009138 1453489 1453489 VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 CDD RADIOASSAY, VITAMIN B12 2 VITROS
38 10758750009077 1435205 1435205 VITROS Immunodiagnostic Products Testosterone Reagent Pack CDZ RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE 1 VITROS
39 10758750009053 1420025 1420025 VITROS Immunodiagnostic Products Metabolism Controls JJX Single (specified) analyte controls (assayed and unassayed) 1 VITROS
40 10758750009015 1410646 1410646 VITROS Immunodiagnostic Products Total Thyroid Controls JJY Multi-analyte controls, all kinds (assayed) 1 VITROS
41 10758750008995 1393396 1393396 VITROS Immunodiagnostic Products Total T4 Calibrators JIS CALIBRATOR, PRIMARY 2 VITROS
42 10758750008971 1387000 1387000 VITROS Immunodiagnostic Products Free T4 Reagent Pack CEC RADIOIMMUNOASSAY, FREE THYROXINE 2 VITROS
43 10758750008926 1372101 1372101 VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator LOL Hepatitis a test (antibody and igm antibody) 2 VITROS
44 10758750008902 1350198 1350198 VITROS Immunodiagnostic Products LH Reagent Pack CEP RADIOIMMUNOASSAY, LUTEINIZING HORMONE 1 VITROS
45 10758750008834 1322528 1322528 VITROS Immunodiagnostic Products Total T3 Reagent Pack CDP RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE 2 VITROS
46 10758750008810 1318930 1318930 VITROS Immunodiagnostic ProductsEstradiol Calibrators JIS CALIBRATOR, PRIMARY 2 VITROS
47 10758750008803 1315654 1315654 VITROS Immunodiagnostic Products Free Thyroid Controls JJY Multi-analyte controls, all kinds (assayed) 1 VITROS
48 10758750008797 1315589 1315589 VITROS Immunodiagnostic Products Free T3 Reagent Pack CDP RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE 2 VITROS
49 10758750008766 1311075 1311075 VITROS Immunodiagnostic Products Folate Calibrators JIS CALIBRATOR, PRIMARY 2 VITROS
50 10758750008742 1306026 1306026 VITROS Immunodiagnostic ProductsTestosterone Calibrators JIX CALIBRATOR, MULTI-ANALYTE MIXTURE 2 VITROS
Other products with the same Product Code "QKO"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 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.
2 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.
3 08056771103664 311460 LIAISON® SARS-CoV-2 S1/S2 IgG DIASORIN SPA
4 07333066021287 DECC066630 DECC066630 EliA SARS-CoV-2-Sp1 IgG Well EliA SARS-CoV-2-Sp1 IgG Well PHADIA AB
5 07333066021232 83-0042-11 83-0042-11 EliA CoV Positive Control C1 250 EliA CoV Positive Control C1 250 PHADIA AB
6 06973774259803 25 Tests/Kit REF:207.01.25.02 Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit BIOHIT HEALTHCARE (HEFEI) CO., LTD.
7 06952804805029 1.0 Fastep COVID-19 IgG/IgM Rapid Test Device ASSURE TECH. (HANGZHOU) CO., LTD.
8 05700571113011 K1919 SARS-CoV-2 IgG ELISA Kit SARS-CoV-2 IgG ELISA Kit AGILENT TECHNOLOGIES, INC.
9 05060169695962 IS-ID6502 IDS SARS-COV-2 IgG IMMUNODIAGNOSTIC SYSTEMS LIMITED
10 04049016150244 EI 2606-9601-20 G Anti-SARS-CoV-2 S1 Curve ELISA (IgG) EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
11 04049016145554 EI 2606-9601 G Anti-SARS-CoV-2 ELISA (IgG) EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
12 04049016145547 EI 2606-9601 A Anti-SARS-CoV-2 ELISA (IgA) EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
13 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.
14 00630414607139 11417771 K7771 Vista COV2G Assay Vista COV2G Assay SIEMENS HEALTHCARE DIAGNOSTICS INC.
15 00630414607030 11417770 RF870 Dimension CV2G Assay Dimension CV2GAssay SIEMENS HEALTHCARE DIAGNOSTICS INC.
16 00630414605500 11417414 K7414 Vista COV2T Assay Vista COV2T Assay SIEMENS HEALTHCARE DIAGNOSTICS INC.
17 00630414605494 11417413 KC813 DV/DM COV2T/CV2T CAL DV/DM COV2T/CV2T CAL SIEMENS HEALTHCARE DIAGNOSTICS INC.
18 00630414605425 11417415 KC815 DV/DM COV2T/CV2T POS/NEG CTRL DV/DM COV2T/CV2T POS/NEG CTRL SIEMENS HEALTHCARE DIAGNOSTICS INC.
19 00630414605418 11417412 RF812 Dimension CV2T Assay Dimension CV2T Assay SIEMENS HEALTHCARE DIAGNOSTICS INC.
20 00380740193867 06S6130 06S6130 AdviseDx SARS-CoV-2 IgG II Reagent Kit 1000 Test Alinity ABBOTT IRELAND DIAGNOSTICS
21 00380740193843 06S6120 06S6120 AdviseDx SARS-CoV-2 IgG II Reagent Kit 200 Test Alinity ABBOTT IRELAND DIAGNOSTICS
22 00380740193829 06S6110 06S6110 AdviseDx SARS-CoV-2 IgG II Control Kit Alinity ABBOTT IRELAND DIAGNOSTICS
23 00380740193805 06S6101 06S6101 AdviseDx SARS-CoV-2 IgG II Calibrator Kit Alinity ABBOTT IRELAND DIAGNOSTICS
24 00380740193782 06S6030 06S6030 AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
25 00380740193768 06S6020 06S6020 AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
26 00380740193744 06S6010 06S6010 AdviseDx SARS-CoV-2 IgG II Control Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
27 00380740193720 06S6001 06S6001 AdviseDx SARS-CoV-2 IgG II Calibrator Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
28 00380740192167 06R8730 06R8730 AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
29 00380740192150 06R8630 06R8630 SARS-CoV-2 IgG Reagent Kit 500 Tests ARCHITECT ABBOTT LABORATORIES
30 00380740192136 06R9030 06R9030 SARS-CoV-2 IgG Reagent Kit 1000 Tests Alinity ABBOTT LABORATORIES
31 00380740192129 06R9020 06R9020 SARS-CoV-2 IgG Reagent Kit 200 Tests Alinity ABBOTT LABORATORIES
32 00380740192112 06R9010 06R9010 SARS-CoV-2 IgG Control Kit Alinity ABBOTT LABORATORIES
33 00380740192105 06R9001 06R9001 SARS-CoV-2 IgG Calibrator Kit Alinity ABBOTT LABORATORIES
34 00380740192099 06R9130 06R9130 AdviseDx SARS-CoV-2 IgM Reagent Kit 1000 Test Alinity ABBOTT IRELAND DIAGNOSTICS
35 00380740192082 06R9120 06R9120 AdviseDx SARS-CoV-2 IgM Reagent Kit 200 Test Alinity ABBOTT IRELAND DIAGNOSTICS
36 00380740192075 06R9110 06R9110 AdviseDx SARS-CoV-2 IgM Control Kit Alinity ABBOTT IRELAND DIAGNOSTICS
37 00380740192068 06R9101 06R9101 AdviseDx SARS-CoV-2 IgM Calibrator Kit Alinity ABBOTT IRELAND DIAGNOSTICS
38 00380740191863 06R8720 06R8720 AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
39 00380740191856 06R8710 06R8710 AdviseDx SARS-CoV-2 IgM Control Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
40 00380740191849 06R8701 06R8701 AdviseDx SARS-CoV-2 IgM Calibrator Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
41 00380740191832 06R8620 06R8620 SARS-CoV-2 IgG Reagent Kit 100 Tests ARCHITECT ABBOTT LABORATORIES
42 00380740191825 06R8610 06R8610 SARS-CoV-2 IgG Control Kit ARCHITECT ABBOTT LABORATORIES
43 00380740191818 06R8601 06R8601 SARS-CoV-2 IgG Calibrator Kit ARCHITECT ABBOTT LABORATORIES
44 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.
45 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.
46 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.
47 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.
48 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.
49 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.
50 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.