Other products from "QUALIGEN INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 10816467020157 Vit. D Immunoassay 25000068, 25000073 30 Test Vit. D Immunoassay Complete Kit w/Cal and Control MRG System, Test, Vitamin D FastPack® IP Vitamin D Kit Complete
2 10816467020126 hCG Immunoassay 25000044 30 Test Ported hCG Immunoassay Kit JHI Visual, Pregnancy Hcg, Prescription Use FastPack® IP hCG Kit (30)
3 10816467020010 TPSA Immunoassay 25000001 50 Test Non-Ported TPSA Immunoassay Kit LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers FastPack® Total PSA Kit (50)
4 00816467020372 Pro System 08000067, 08000067-R, 08000067-X RoHS Compliant 7-chamber FastPack System JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 1 FastPack® Pro System
5 00816467020075 TPSA Verifier 25000017 JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Method Verification Kit - PSA
6 20816467020086 TSH Immunoassay 25000042 30 Test Ported TSH Immunoassay Kit JLW Radioimmunoassay, Thyroid-Stimulating Hormone FastPack® IP TSH Kit (30)
7 00816467020167 PSA Controls 25000003 Two levels of controls for the following assays: TPSA, FPSAFPSA is not available Two levels of controls for the following assays: TPSA, FPSAFPSA is not available in the US. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Control Kit - PSA
8 20816467020055 FT4 Immunoassay 25000043 30 Test Ported FT4 Immunoassay Kit CEC Radioimmunoassay, Free Thyroxine FastPack® IP Free T4 Kit (30)
9 00816467020044 Testo Cal 25000014 JIT Calibrator, Secondary 2 Calibrator Kit - Testosterone
10 30816467020038 Testo Immunoassay 25000058 90 Test Ported Testo Immunoassay Kit CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone FastPack® IP Testo Kit (90)
11 20816467020017 TPSA Immunoassay 25000040 30 Test Ported TPSA Immunoassay Kit LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers FastPack® IP Total PSA Kit (30)
12 10816467020034 Testo Immunoassay 25000009 50 Test Non-Ported Testo Immunoassay Kit CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone FastPack® Testo Kit (50)
13 00816467020105 hCG Cal 25000035 JIT Calibrator, Secondary 2 Calibrator Kit – hCG
14 00816467020143 Vit. D Verifier 25000064, 25000074 JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Method Verification Kit - Vitamin D
15 00816467020020 TPSA Cal 25000002 JIT Calibrator, Secondary 2 Calibrator Kit - PSA
16 00816467020006 IP System 08000043, 08000043-R, 08000043-X JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 1 FastPack® IP System
17 00816467020099 TSH Cal 25000024 JIT Calibrator, Secondary 2 Calibrator Kit – TSH
18 00816467020068 FT4 Cal 25000016 JIX Calibrator, Multi-Analyte Mixture 2 Calibrator Kit – Free T4
19 00816467020334 IP System 08000043-C, 08000043-CR RoHS Compliant FastPack System JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 1 FastPack® IP System
20 00816467020112 hCG Diluent 25000036 Used to dilute the sample if the test result reads outside the assay range. Max Used to dilute the sample if the test result reads outside the assay range. Maximum two serial dilutions per sample. JHI Visual, Pregnancy Hcg, Prescription Use 2 FastPack® IP hCG Diluent Kit (25)
21 20816467020031 Testo Immunoassay 25000041 30 Test Ported Testo Immunoassay Kit CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone FastPack® IP Testo Kit (30)
22 00816467020136 Multi-Analyte Controls 25000056 Two control levels for the following assays: TPSA, Testo, FT4, TSH, hCG JJY Multi-Analyte Controls, All Kinds (Assayed) 1 FastPack® Control Kit
23 30816467020014 TPSA Immunoassay 25000057 90 Test Ported TPSA Immunoassay Kit LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers FastPack® IP Total PSA Kit (90)
24 20816467020345 FastPack® IP SHBG 30 Immunoassay 25000081 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls JJX,JIT,CDZ Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondar Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondary,Radioimmunoassay, Testosterones And Dihydrotestosterone FastPack® IP SHBG
25 10816467020348 FastPack® IP SHBG 60 Immunoassay 25000080 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control JJX,JIT,CDZ Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondar Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondary,Radioimmunoassay, Testosterones And Dihydrotestosterone FastPack® IP SHBG
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.