No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 15099590704087 | B1017-435 | Neg Urine Combo 85 | LQM,LTW,LRG,JWY,LTT | Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Inst Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems,Manual Antimicrobial Susceptibility Test Systems,Panels, Test, Susceptibility, Antimicrobial | MicroScan | ||
2 | 15099590704070 | B1017-434 | Neg Urine Combo 84 | LQM,LTW,LRG,JWY,LTT | Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Inst Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems,Manual Antimicrobial Susceptibility Test Systems,Panels, Test, Susceptibility, Antimicrobial | MicroScan | ||
3 | 15099590765385 | C89645 | Neg Urine Combo 103 | JWY,LRG,LTT,LTW,LQM | Manual Antimicrobial Susceptibility Test Systems,Instrument For Auto Reader & In Manual Antimicrobial Susceptibility Test Systems,Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems,Panels, Test, Susceptibility, Antimicrobial,Susceptibility Test Cards, Antimicrobial,Gram Negative Identification Panel | 1 | MicroScan | |
4 | 15099590733919 | C48640 | Neg Urine Combo 90 | LQM,LTW,LTT,LRG,JWY | Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Pane Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Panels, Test, Susceptibility, Antimicrobial,Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems,Manual Antimicrobial Susceptibility Test Systems | MicroScan | ||
5 | 15099590707118 | DxA 5000 | DxA 5000 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | DxA 5000 | |
6 | 15099590540210 | 6607098 | 6607098 | IMMUNO-TROL Low Cells | JPK | Mixture, Hematology Quality Control | 2 | IMMUNO-TROL Low Cells |
7 | 15099590250683 | 7546914 | 7546914 | COULTER LATRON Control | GKL | Counter, Cell, Automated (Particle Counter) | 2 | COULTER Latron |
8 | 15099590060206 | OSR6637 | Bicarbonate | KHS | Enzymatic, Carbon-Dioxide | 2 | AU | |
9 | 15099590222925 | 465980 | 465980 | Vigil Lipid Control Level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Vigil |
10 | 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. | QKO | Reagent, Coronavirus Serological | Access SARS-CoV-2 IgG II Calibrator | |
11 | 15099590701574 | C11478 | UniCel DxH 900 Coulter Cellular Analysis System | GKZ | Counter, Differential Cell | 2 | DxH 900 Hematology System | |
12 | 15099590672539 | B36633 | B36633 | CYTO-STAT /COULTER CLONE MsIgG2a-RD1 (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT /COULTER CLONE MsIgG2a-RD1 |
13 | 15099590672522 | B36631 | B36631 | CYTO-STAT /COULTER CLONE Mo2-FITC (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT /COULTER CLONE Mo2-FITC |
14 | 15099590672461 | B36623 | B36623 | CYTO-STAT /COULTER CLONE MsIgG2b-FITC (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT /COULTER CLONE MsIgG2b-FITC |
15 | 15099590672454 | B36536 | B36536 | CYTO-STAT /COULTER CLONE B4-RD1 (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT /COULTER CLONE B4-RD1 |
16 | 15099590663827 | 8448044 | 8448044 | COULTER Isoton III Diluent 20L | GIF | Diluent, Blood Cell | 1 | COULTER Isoton III Diluent |
17 | 15099590663803 | 8448177 | 8448177 | COULTER Lyse S III diff Lytic Reagent (5L) | GGK | Products, Red-Cell Lysing Products | 1 | COULTER Lyse S III diff Lytic Reagent |
18 | 15099590663797 | 8448155 | 8448155 | COULTER Lyse S III diff Lytic Reagent (1L) | GGK | Products, Red-Cell Lysing Products | 1 | COULTER Lyse S III diff Lytic Reagent |
19 | 15099590638191 | 378600 | 378600 | COULTER PrepPlus 2 | PER | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cyto Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | 1 | PrepPlus 2 |
20 | 15099590625856 | 8546733 | 8546733 | COULTER Isoton III Diluent (20L) | GIF | Diluent, Blood Cell | 1 | COULTER Isoton III Diluent |
21 | 15099590625771 | 8547148 | 8547148 | COULTER Isoton 4 Diluent (20L) | GIF | Diluent, Blood Cell | 1 | COULTER Isoton 4 Diluent |
22 | 15099590624903 | A31590 | A31590 | The Access Toxo IgG QC is intended for monitoring system performance of the Acce The Access Toxo IgG QC is intended for monitoring system performance of the Access Toxo IgG assay. | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Access Toxo IgG QC |
23 | 15099590624811 | 33209 | 33209 | The Access CEA QC (BSA matrix) controls are intended for monitoring the system p The Access CEA QC (BSA matrix) controls are intended for monitoring the system performance of immunoenzymatic procedures for the quantitative measurement of Carcinoembryonic Antigen (CEA) using Access CEA reagents. | DHX | System, Test, Carcinoembryonic Antigen | 2 | Access CEA QC |
24 | 15099590583996 | Power Link | B05033 | Power Link | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Power Link |
25 | 15099590572839 | UPS (CXP) | 626553 | Cytomics FC 500 with CXP Software | GKZ | Counter, Differential Cell | 2 | Cytomics FC500 |
26 | 15099590572822 | UPS (MPL) | 626554 | Cytomics FC 500 MPL with MXP Software | GKZ | Counter, Differential Cell | 2 | Cytomics FC500 |
27 | 15099590542863 | 6602940 | 6602940 | COULTER CLONE MsIgM-FITC | GKZ | Counter, Differential Cell | 2 | CC MsIgM-RD1 |
28 | 15099590542535 | 6602872 | 6602872 | COULTER CLONE MsIgG1 | GKZ | Counter, Differential Cell | 2 | CC MsIgG1 Isotypic Control |
29 | 15099590542511 | 6602884 | 6602884 | COULTER CLONE MsIgG1-RD1 | GKZ | Counter, Differential Cell | 2 | CC MsIgG1-RD1 |
30 | 15099590542399 | 6603838 | 6603838 | COULTER CLONE KC56 (T-200)-FITC (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | COULTER CLONE KC56 (T-200)-FITC |
31 | 15099590542313 | 8547008 | 8547008 | IsoFlow Sheath Fluid | GIF | Diluent, Blood Cell | 1 | ISOFLOW SHEATH FLUID |
32 | 15099590541590 | 6602507 | 6602507 | COULTER CLONE Mo2-FITC | GKZ | Counter, Differential Cell | 2 | CC Mo2-FITC (CD14-FITC) |
33 | 15099590541378 | 6603822 | 6603822 | CYTO-STAT/COULTER CLONE 3A1-RD1 (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT/COULTER CLONE 3A1-RD1 |
34 | 15099590541354 | 6603825 | 6603825 | COULTER CLONE 3A1-FITC (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | COULTER CLONE 3A1-FITC |
35 | 15099590540951 | 6602381 | 6602381 | COULTER CLONE B1-FITC | GKZ | Counter, Differential Cell | 2 | CC B1-FITC (CD20-FITC) |
36 | 15099590540890 | 627808 | 627808 | FlowCARE PLG CD4 Reagent (CD45-FITC/CD4-PE) | GKZ | Counter, Differential Cell | 2 | FlowCARE PLG CD4 Reagent |
37 | 15099590540883 | 6603909 | 6603909 | CYTO-STAT/COULTER CLONE Mo2-RD1/KC56(T-200)-FITC | GKZ | Counter, Differential Cell | 2 | CS/CC Mo2-RD1/KC56(T-200)-FITC |
38 | 15099590540449 | 6607077 | 6607077 | IMMUNO-TROL Cells | JPK | Mixture, Hematology Quality Control | 2 | IMMUNO-TROL Cells |
39 | 15099590539757 | 6604500 | 6604500 | CYTO-STAT/COULTER CLONE Mo2-RD1 | GKZ | Counter, Differential Cell | 2 | CS/CC Mo2-RD1 (CD14-RD1) |
40 | 15099590539719 | 6604621 | 6604621 | CYTO-STAT/COULTER CLONE CD3(IgG1)-RD1 | GKZ | Counter, Differential Cell | 2 | CS/CC CD3(IgG1)-RD1 |
41 | 15099590539207 | 6602705 | 6602705 | COULTER CLONE NKH-1 (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | COULTER CLONE NKH-1 |
42 | 15099590250973 | 8547196 | 8547196 | COULTER LH Series Retic Pak Reagent Kit | GGK | Products, Red-Cell Lysing Products | 1 | COULTER LH Series Retic Pak Reagent Kit |
43 | 15099590234089 | 721542 | 721542 | LH Series Cleaner (5L) | JCB | Detergent | 1 | LH Series Cleaner |
44 | 15099590250935 | 8546859 | 8546859 | IsoFlow Sheath Fluid | GIF | Diluent, Blood Cell | 1 | ISOFLOW SHEATH FLUID |
45 | 15099590250751 | 7547201 | 7547201 | COULTER TruColor Giemsa Stain | KQC | Stains, Hematology | 1 | COULTER TruColor Giemsa Stain |
46 | 15099590250720 | 7547180 | 7547180 | COULTER TruColor Wright Stain Buffer | KQC | Stains, Hematology | 1 | COULTER TruColor Wright Stain Buffer |
47 | 15099590250690 | 7546915 | 7546915 | COULTER LATRON Primer | GKL | Counter, Cell, Automated (Particle Counter) | 2 | COULTER Latron |
48 | 15099590233785 | 628028 | 628028 | COULTER Retic-X Cell Control | JPK | Mixture, Hematology Quality Control | 2 | COULTER Retic-X |
49 | 15099590233686 | 628017 | 628017 | COULTER DxH Diluent | GIF | Diluent, Blood Cell | 1 | COULTER DxH Diluent |
50 | 15099590232931 | 177017 | 177017 | QuickComp 4 Kit | GKZ | Counter, Differential Cell | 2 | QuickCOMP 4 Kit |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10758750006793 | 6801728 | 6801728 | VITROS Chemistry Products dLDL Reagent | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
2 | 07350108630139 | 10-1143-01 | 10-1143-01 | The Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quan The Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quantitative measurement of oxidized low density lipoproteins (oxidized LDL) in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. | Mercodia Oxidized LDL ELISA | MERCODIA AB |
3 | 07350108630108 | 10-1143-01 | 10-1143-01 | The Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quan The Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quantitative measurement of oxidized low density lipoproteins (oxidized LDL) in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. | Mercodia Oxidized LDL ELISA | MERCODIA AB |
4 | 05055273213966 | CH2656 | Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cho Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cholesterol in human serum and plasma. | DIRECT LDL-CHOLESTEROL (LDL) | RANDOX LABORATORIES LIMITED | |
5 | 05055273208498 | CH8312 | DIRECT LDL-CHOLESTEROL (LDL) | RANDOX LABORATORIES LIMITED | ||
6 | 05055273208450 | CH8032 | DIRECT LDL-CHOLESTEROL (LDL) | RANDOX LABORATORIES LIMITED | ||
7 | 05055273201307 | CH3841 | CH3841 | In Vitro device for the quantitative determination of LDL-Cholesterol in serum and plasma. | LDL | RANDOX LABORATORIES LIMITED |
8 | 00857969006525 | SA1040 | SA1040 | LDL-C Reagent | ACE | ALFA WASSERMANN, INC. |
9 | 00857969006471 | RX1026 | RX1026 | LDL-C Reagent | ACE | ALFA WASSERMANN, INC. |
10 | 00842768015267 | 10445096 | K3131 | Low-Density Lipoprotein Cholesterol Flex® reagent cartridge, 180 Tests | Dimension Vista® Flex® reagent cartridge LDLC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
11 | 00842768005350 | 10444890 | DF131 | Automated LDL Cholesterol Flex® reagent cartridge, 120 tests | Dimension® Flex® reagent cartridge ALDL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
12 | 00817439021021 | LDL600 | LDL600 | Reagent for the in vitro quantitative kinetic determination of lactate dehydroge Reagent for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum using the Mindray BS-200 analyzer.3 x 40ml, 3 x 14ml | MedTest Dx, Inc. autoLDL | MEDTEST DX, INC. |
13 | 00817439021014 | LDL480 | LDL480 | Reagent for the direct quantitative determination of low density lipoprotein cho Reagent for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma using the Mindray BS-480 analyzer. For in vitro diagnostic use only.4 x 60 ml, 4 x 20 ml | MedTest Dx, Inc. autoLDL Cholestrol | MEDTEST DX, INC. |
14 | 00817302024623 | ST661 | ST661 | LDL Cholesterol Reagent (LDL) w/ Calibrator | CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT ST661 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
15 | 00817302024487 | DT661 | DT661 | LDL Cholesterol Direct (LDLD) w/ Calibrator | CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT DT661 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
16 | 00817302024227 | BL661 | BL661 | LDL Cholesterol Direct (LDLD) w/ Calibrator | CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT BL661 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
17 | 00817302024142 | AU-661 | AU-661 | LDL Cholesterol Reagent (LDL) w/ Calibrator | CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
18 | 00817302022667 | CC667 | CC667 | LDLD (LDL Cholesterol Direct) w/ cal 2 x 200 tests | CAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
19 | 00811727016218 | 16-L7574-400 | 16-L7574-400 | Pointe autoLDL Cholesterol Reagent packaged for use on the Mindray BA800. 5 Pointe autoLDL Cholesterol Reagent packaged for use on the Mindray BA800. 5 x 60ml R1, 5 x 20ml R2. For the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only. | Pointe autoLDL Cholesterol Reagent | POINTE SCIENTIFIC, INC. |
20 | 00811727015914 | 14-L7574-320 | 14-L7574-320 | Pointe autoLDL Cholesterol Reagent packaged for use on the Mindray BS480. 4 x 60 Pointe autoLDL Cholesterol Reagent packaged for use on the Mindray BS480. 4 x 60ml R1, 4 x 20ml R2. For the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only. | Pointe autoLDL Cholesterol Reagent | POINTE SCIENTIFIC, INC. |
21 | 00811727015082 | OL974-480 | OL974-480 | Pointe Scientific, Inc. autoLDL Cholesterol Reagent is for the direct quantitati Pointe Scientific, Inc. autoLDL Cholesterol Reagent is for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma on Olympus Analyzers. For in vitro diagnostic use only. 6 x 60ml, 6 x 20ml | Pointe Scientific, Inc. autoLDL Cholesterol | POINTE SCIENTIFIC, INC. |
22 | 00811727013637 | 12-L7574-162 | 12-L7574-162 | For the direct quantitative determination of low density lipoprotein cholesterol For the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only. | autoLDL | POINTE SCIENTIFIC, INC. |
23 | 00811727013071 | HL974-480 | HL974-480 | autoLDL Cholesterol Reagent is for the direct quantitative determination of low autoLDL Cholesterol Reagent is for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only. 6 x 60ml, 6 x 20ml. | Pointe Scientific autoLDL Cholesterol | POINTE SCIENTIFIC, INC. |
24 | 00811727011787 | L7574-320 | L7574-320 | Reagent for the direct quantitative determination of low density lipoprotein cho Reagent for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only.1 x 240ml, 1 x 80ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
25 | 00811727011770 | L7574-80 | L7574-80 | Reagent for the direct quantitative determination of low density lipoprotein cho Reagent for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only.1 x 60ml, 1 x 20ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
26 | 00811727011763 | L7574-40 | L7574-40 | Reagent for the direct quantitative determination of low density lipoprotein cho Reagent for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only. 1 x 30ml, 1 x 10ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
27 | 00657498001578 | S0710-540 | S0710-540 | For the qualitative determination of LDL Cholesterol in serum and plasma. | Sirrus® Direct LDL Cholesterol LiquiColor® | STANBIO LABORATORY, L.P. |
28 | 00657498000700 | 0710-080 | 0710-080 | For the Quantitative Determination of Low Density Lipoprotein (LDL) Cholesterol For the Quantitative Determination of Low Density Lipoprotein (LDL) Cholesterol in Human Serum or Plasma. | Direct LDL Cholesterol LiquiColor® | STANBIO LABORATORY, L.P. |
29 | 00630414611037 | 11537214 | 11537214 | LDL Cholesterol (LDLC) Atellica CH Assay 1600 Tests | Atellica CH LDLC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
30 | 00630414596181 | 11097632 | 11097632 | LDL Cholesterol Direct (D LDL) Atellica CH - RGT 1600T | Atellica CH DLDL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
31 | 00630414470542 | 10311891 | B01-4760-01 | LDL Cholesterol - ADVIA Chem. - RGT - 4x188 tests | ADVIA® Chemistry Direct LDL Cholesterol Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
32 | 00628063400775 | SK5665-20 | SK5665-20 | LDL Cholesterol | SEKISUI DIAGNOSTICS, LLC | |
33 | 00628063400768 | 80-5729-02 | 80-5729-02 | N-geneous LDL-ST Cholesterol Reagent (R2) | SEKISUI DIAGNOSTICS, LLC | |
34 | 00628063400751 | 80-5727-02 | 80-5727-02 | N-geneous LDL-ST Cholesterol Reagent (R1) | SEKISUI DIAGNOSTICS, LLC | |
35 | 00628063400737 | 80-5714-00 | 80-5714-00 | N-geneous LDL-ST Cholesterol Reagent (R2) | SEKISUI DIAGNOSTICS, LLC | |
36 | 00628063400720 | 80-5665-01 | 80-5665-01 | N-geneous LDL-ST Cholesterol Reagent (R1) | SEKISUI DIAGNOSTICS, LLC | |
37 | 00386100002206 | 10224-4 | 10224-4 | LDL Cholesterol Reagent Kit for use with EasyRA Analyzers | LDL CHOL Reagent Kit | MEDICA CORPORATION |
38 | B3959930030 | 9930030 | 9930030 | NMR Reference Standard used for the Vantera Clinical Analyzer. | NMR Reference Standard | LABCORP OF AMERICA |
39 | B3959920030 | 9920030 | 9920030 | Sample Diluent 1 used for the Vantera Clinical Analyzer. | NMR Diluent 1 | LABCORP OF AMERICA |
40 | B3959910030 | 9910030 | 9910030 | WASH Solution used for the Vantera Clinical Analyzer | NMR WASH Solution | LABCORP OF AMERICA |
41 | B3959900300 | 9900300 | 9900300 | Clinical Analyzer | Vantera Clinical Analyzer | LABCORP OF AMERICA |
42 | 15099590625627 | 969706 | 969706 | Direct LDL Cholesterol Reagent (LDLD 2 x 100) | Synchron | BECKMAN COULTER, INC. |