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 | 00817439021045 | LIPC480 | LIPC480 | The Lipid Control set are assayed Lipid Controls produced from fresh human sera The Lipid Control set are assayed Lipid Controls produced from fresh human sera to monitor the accuracy and precision of quantitative lipid determinations of human sera specimens.6 x 3 ml | MedTest DX, Inc. Lipid Controls | MEDTEST DX, INC. |
2 | 00817439020901 | HNC200 | HNC200 | MedTest DX Control Level 1 is a lyophilized human based control serum for use in MedTest DX Control Level 1 is a lyophilized human based control serum for use in the quality control of diagnostic assays. Human-sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control of reproducibility. Constituent concentrations are available at 2 levels. Size: 10 x 5 ml | MedTest DX Control Level 1 | MEDTEST DX, INC. |
3 | 00817439020895 | HEC200 | HEC200 | MedTest DX Control Level 2 is a lyophilized human based control serum for use in MedTest DX Control Level 2 is a lyophilized human based control serum for use in the quality control of diagnostic assays. Human-sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control of reproducibility. Constituent concentrations are available at 2 levels. Size: 10 x 5 ml | MedTest DX Control Level 2 | MEDTEST DX, INC. |
4 | 00817439020031 | 3003 | 3003 | This product is intended for in-vitro use only, in the quality control of Direct This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipoprotein A-1, Apolipoprotein B, cholesterol and triglyceride methods on clinical chemistry systems. 6 x 3 ml | Direct Lipid Control L3 | MEDTEST DX, INC. |
5 | 00817439020024 | 3002 | 3002 | This product is intended for in-vitro use only, in the quality control of Direct This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipoprotein A-1, Apolipoprotein B, cholesterol and triglyceride methods on clinical chemistry systems. 6 x 3 ml | Direct Lipid Control L2 | MEDTEST DX, INC. |
6 | 00817439020017 | 3001 | 3001 | This product is intended for in-vitro use only, in the quality control of Direct This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipoprotein A-1, Apolipoprotein B, cholesterol and triglyceride methods on clinical chemistry systems.6 x 3 ml | Direct Lipid Control L1 | MEDTEST DX, INC. |
7 | 00817439020000 | 3000 | 3000 | This product is intended for in-vitro use only, in the quality control of Direct This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipoprotein A-1, Apolipoprotein B, cholesterol and triglyceride methods on clinical chemistry systems.6 x 3 ml | Direct Lipid Control Set | MEDTEST DX, INC. |
8 | 00817274022368 | CON 2-5U | CON 2-5U | Chemistry Control Level 2 (5mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
9 | 00817274022351 | CON1-5U | CON1-5U | CHEMISTRY CONTROL LEVEL 1 ( 5mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
10 | 00817274022306 | LIPC1-3U | LIPC1-3U | HDL/LDL CHOLESTEROL (LIPID) CONTROL LEVEL 1 (3mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
11 | 00817274022290 | LIPC2-3U | LIPC2-3U | HDL/LDL CHOLESTEROL (LIPID) CONTROL LEVEL 2 (3mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
12 | 00817274021729 | LIPC1-3 | HDL/LDL CHOLESTEROL CONTROL (5x 3mL L1, 5x 3mL L2) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
13 | 00817274021286 | CKMC2-3 | CK MB CONTROL LEVEL II (1x 3mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
14 | 00817274021279 | CKMC1-3 | CK MB CONTROL LEVEL I (1x 3mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
15 | 00817274021163 | CON 2-5 | CON 205 Chemistry Control Level | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
16 | 00817274021156 | CON1-5 | CHEMISTRY CONTROL LEVEL 1 (10x 5mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
17 | 00817274021149 | DG-CON1-5 | CHEMISTRY CONTROL LEVEL 1 (10x 5mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
18 | 00817274020920 | PH6000-UV | BILIRUBIN CALIBRATOR, 1mL AMPULE GENERIC LABEL | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
19 | 00817238011643 | 98232 | Cardiac Calibration Verifiers for Beckman Systems | Cardiac Calibration Verifiers for Beckman Systems | CLINIQA CORPORATION | |
20 | 00817238011636 | 98505 | Cardiac Calibration Verifiers for Roche Systems | Cardiac Calibration Verifiers for Roche Systems | CLINIQA CORPORATION | |
21 | 00817238011629 | 91492 | Cardiac Control Complete +TnT level 3 | Cardiac Control Complete +TnT level 3 | CLINIQA CORPORATION | |
22 | 00817238011612 | 91491 | Cardiac Control Complete +TnT level 2 | Cardiac Control Complete +TnT level 2 | CLINIQA CORPORATION | |
23 | 00817238011605 | 91490 | Cardiac Control Complete +TnT level 1 | Cardiac Control Complete +TnT level 1 | CLINIQA CORPORATION | |
24 | 00817238011599 | 93222 | WHOLE BLOOD VOLATILES CONTTROL LEVEL 2 | WHOLE BLOOD VOLATILES CONTTROL LEVEL 2 | CLINIQA CORPORATION | |
25 | 00817238011582 | 93221 | WHOLE BLD VOLATILES CONTROL LEVEL 1 | WHOLE BLD VOLATILES CONTROL LEVEL 1 | CLINIQA CORPORATION | |
26 | 00817238011513 | 91444 | LQC Cardiac Control CS, Tri-level kit | LQC Cardiac Control CS, Tri-level kit | CLINIQA CORPORATION | |
27 | 00817238011315 | 98303 | Protein 3 Calibration Verifier set for the BCI AU | Protein 3 Calibration Verifier set for the BCI AU | CLINIQA CORPORATION | |
28 | 00817238010745 | 98302 | Protein 2 Calibration Verifier set for the BCI AU | Protein 2 Calibration Verifier set for the BCI AU | CLINIQA CORPORATION | |
29 | 00817238010691 | 98504 | Protein 4 Calibration verifier Set for the Roche Integra | Protein 4 Calibration verifier Set for the Roche Integra | CLINIQA CORPORATION | |
30 | 00817238010684 | 98503 | Protein 3 Calibration verifier Set for the Roche Integra | Protein 3 Calibration verifier Set for the Roche Integra | CLINIQA CORPORATION | |
31 | 00817238010677 | 98502 | Protein 2 Calibration Verifier Set for the Roche Integra | Protein 2 Calibration Verifier Set for the Roche Integra | CLINIQA CORPORATION | |
32 | 00817238010660 | 98501 | LiniCAL Calibration Verifiers Protein 1 for che Systems Levels A-F | LiniCAL Calibration Verifiers Protein 1 for che Systems Levels A-F | CLINIQA CORPORATION | |
33 | 00817238010585 | R83083 | Assay Control Serum Level 2 | Assay Control Serum Level 2 | CLINIQA CORPORATION | |
34 | 00817238010578 | R83082 | Assay Control Serum Level 1 | Assay Control Serum Level 1 | CLINIQA CORPORATION | |
35 | 00817238010479 | 95505 | Alcohol/Ammonia Control Bi-level | Alcohol/Ammonia Control Bi-level | CLINIQA CORPORATION | |
36 | 00817238010462 | 95502 | Alcohol/Ammonia Control level 2 | Alcohol/Ammonia Control level 2 | CLINIQA CORPORATION | |
37 | 00817238010455 | 95501 | Alcohol/Ammonia Control level 1 | Alcohol/Ammonia Control level 1 | CLINIQA CORPORATION | |
38 | 00817238010448 | 94109 | Tri-Level Immunoassay Control Minipack | Tri-Level Immunoassay Control Minipack | CLINIQA CORPORATION | |
39 | 00817238010431 | 94104 | Liquid QC Immunoassay Control Tri-Level | Liquid QC Immunoassay Control Tri-Level | CLINIQA CORPORATION | |
40 | 00817238010424 | 94103 | Immunoassay Control Level 3 | Immunoassay Control Level 3 | CLINIQA CORPORATION | |
41 | 00817238010417 | 94102 | Immunoassay Control Level 2 | Immunoassay Control Level 2 | CLINIQA CORPORATION | |
42 | 00817238010400 | 94101 | Immunoassay Control Level 1 | Immunoassay Control Level 1 | CLINIQA CORPORATION | |
43 | 00817238010325 | 97109 | Urine Chemistry Control Bi-Level | Urine Chemistry Control Bi-Level | CLINIQA CORPORATION | |
44 | 00817238010318 | 97105 | Urine Chemistry Control Bi-Level | Urine Chemistry Control Bi-Level | CLINIQA CORPORATION | |
45 | 00817238010295 | 91505 | LIQUID QC LIPID CONTROL Bi-level | LIQUID QC LIPID CONTROL Bi-level | CLINIQA CORPORATION | |
46 | 00817238010288 | 91502 | LIQUID QC LIPID CONTROL LEVEL 2 | LIQUID QC LIPID CONTROL LEVEL 2 | CLINIQA CORPORATION | |
47 | 00817238010271 | 91501 | LIQUID QC LIPID CONTROL LEVEL | LIQUID QC LIPID CONTROL LEVEL | CLINIQA CORPORATION | |
48 | 00817238010264 | 91435 | Liquid QC Cardiac Marker Control (NT-proBNP/D-Dimer) | Liquid QC Cardiac Marker Control (NT-proBNP/D-Dimer) | CLINIQA CORPORATION | |
49 | 00817238010240 | 91204 | hsCRP Serum Protein Control Tri-Level | hsCRP Serum Protein Control Tri-Level | CLINIQA CORPORATION | |
50 | 00817238010233 | 91203 | hsCRP Serum Protein Control Level 3 | hsCRP Serum Protein Control Level 3 | CLINIQA CORPORATION |