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 | 00630414473383 | 10312275 | T01-3633-54 | ADVIA®120/2120/2120i PEROX SHEATH | ADVIA 120/2120/2120i® Perox Sheath | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
2 | 00630414224329 | 10312283 | T03-3682-54 | ADVIA®120/2120/2120i OPTIpoint™ | ADVIA 120/2120/2120i® OPTIpoint | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
3 | 00630414224305 | 10319591 | T03-3682-01 | ADVIA®120/2120/2120i OPTIpoint™ | ADVIA 120/2120/2120i® OPTIpoint | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
4 | 00630414223032 | 10316869 | T01-3664-01 | ADVIA®120/2120/2120i SHEATH/RINSE | ADVIA 120/2120/2120i® Sheath/Rinse | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
5 | 00630414222950 | 10341169 | T01-3626-52 | IVD Complete Blood Count Kit CN-FREE | ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
6 | 00630414222943 | 10312274 | T01-3625-54 | ADVIA®120/2120/2120i DEFOAMER | ADVIA 120/2120/2120i® Defoamer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
7 | 00630414222929 | 10312272 | T01-3623-01 | ADVIA®120/2120/2120i SHEATH/RINSE | ADVIA 120/2120/2120i® Sheath/Rinse | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
8 | 00630414222912 | 10312271 | T01-3622-54 | ADVIA®120/2120/2120i autoRETIC | ADVIA 120/2120/2120i® AUTOretic | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
9 | 00630414222905 | 10330709 | T01-3622-51 | ADVIA®120/2120/2120i autoRETIC | ADVIA 120/2120/2120i® autoRETIC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
10 | 00630414222899 | 10312270 | T01-3621-52 | ADVIA®120/2120/2120i DIFF TIMEPAC® | ADVIA 120/2120/2120i® DIFF TIMEpac | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
11 | 00630414222882 | 10312269 | T01-3620-52 | ADVIA®120/2120/2120i CBCTIMEPAC® | ADVIA® 120/2120/2120i CBC TIMEpac | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
12 | 00382903492046 | 349204 | 349204 | BD Retic-Count™ Reagent | Reticcount | BECTON, DICKINSON AND COMPANY |
13 | 00382903431731 | 343173 | 343173 | Retic-Count Upgrade Version 1.1 | BD Retic-Count™ | BECTON, DICKINSON AND COMPANY |
14 | 00382903431304 | 343130 | 343130 | Retic-Count S/W Version 1.1 | BD Retic-Count™ | BECTON, DICKINSON AND COMPANY |
15 | 00382903401673 | 340167 | 340167 | BD FACSCount™ Reagent Kit | FACSCount | BECTON, DICKINSON AND COMPANY |
16 | 20816068020201 | 111010 | 111010 | For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Kit - For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains 200 test cartridges. | Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays | ADVANCED INSTRUMENTS, INC. |
17 | 17311091130034 | 113003 | 113003 | HemoCue WBC Microcuvettes 4x40 vial | HemoCue® WBC Microcuvettes | HEMOCUE AB |
18 | 15099590250690 | 7546915 | 7546915 | COULTER LATRON Primer | COULTER Latron | BECKMAN COULTER, INC. |
19 | 15099590250683 | 7546914 | 7546914 | COULTER LATRON Control | COULTER Latron | BECKMAN COULTER, INC. |
20 | 15099590233754 | 628024 | 628024 | COULTER LATRON CP-X Control | COULTER Latron CP-X | BECKMAN COULTER, INC. |
21 | 10837461002475 | Body Fluids Module | 800-3704 | iQ®200 Body Fluids Module (CD only) | iQ®200 | IRIS INTERNATIONAL, INC. |
22 | 10816068020228 | 111012 | 111012 | For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Total Nucleated Cell For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Total Nucleated Cell Reagent Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains three 1.8mL vials of Total Nucleated Cell (TNC) Reagent. | Advanced Instruments GloCyte® Total Nucleated Cell Test Reagent Kit | ADVANCED INSTRUMENTS, INC. |
23 | 10816068020211 | 111011 | 111011 | For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Red Blood Cell Reage For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Red Blood Cell Reagent Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains three 1.8mL vials of Red Blood Cell (RBC) Reagent. | Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit | ADVANCED INSTRUMENTS, INC. |
24 | 10816068020204 | 111096 | 111096 | For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Tray - For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Tray - 25 Cartridges has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains 25 test cartridges. | Advanced Instruments GloCyte® Test Cartridge & Tray - 25 Cartridges | ADVANCED INSTRUMENTS, INC. |
25 | 10816068020174 | 800097 | 800097 | Contains 960 1-200µL pipette tips | Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene | ADVANCED INSTRUMENTS, INC. |
26 | 07311091230010 | 123001 | 123001 | HemoCue WBC Analyzer x10^9 /L | HemoCue® WBC Analyzer | HEMOCUE AB |
27 | 04987562429219 | AR408878 | Automated Hematology Analyzer XP-300 | Automated Hematology Analyzer XP series XP-300 | SYSMEX CORPORATION | |
28 | 04987562402021 | 02318618 | pocH-100i (US) | Automated Hematology Analyzer pocH-100i | SYSMEX CORPORATION | |
29 | 00858604006719 | CEROS | A modular computerized optical analyzer used for evaluation of sperm samples. It A modular computerized optical analyzer used for evaluation of sperm samples. It will provide concentration, velocity, morph and motion parameters, which aid the clinician in evaluation of semen quality. | CEROS | HAMILTON THORNE, INC. | |
30 | 00858604006108 | IVOS | A self-contained computerized optical analyzer used for evaluation of sperm samp A self-contained computerized optical analyzer used for evaluation of sperm samples. It will provide concentration, velocity, morph and motion parameters, which aid the clinician in evaluation of semen quality. | IVOS | HAMILTON THORNE, INC. | |
31 | 00816068020535 | 111014 | 111014 | The RBC Reagent Filtration Kit is used for filtering the RBC Reagent when diluen The RBC Reagent Filtration Kit is used for filtering the RBC Reagent when diluent and reagent counts exceed the acceptance criteria | Advanced Instruments RBC Reagent Filtration Kit | ADVANCED INSTRUMENTS, INC. |
32 | 00816068020245 | 111153 | 111153 | For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Count Template Cartr For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Count Template Cartridge has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. The Count Template Cartridge is a service tool used to check the performance of the GloCyte System. | Advanced Instruments GloCyte® Count Template Cartridge | ADVANCED INSTRUMENTS, INC. |
33 | 00816068020153 | 111076 | 111076 | For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Vacuum Station has b For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Vacuum Station has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Accelerates the capturing of stained cells on the test cartridge. | Advanced Instruments GloCyte® Vacuum Preparation Station Assembly | ADVANCED INSTRUMENTS, INC. |
34 | 00816068020146 | 111000 | 111000 | For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Instrument has been For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Instrument has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Utilizes fluorescence-based technology to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid. | Advanced Instruments GloCyte® Instrument Assembly | ADVANCED INSTRUMENTS, INC. |
35 | 00816068020139 | GloCyte | GloCyte | For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Automated Cell Count For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients. Includes GloCyte instrument, computer, vacuum station, barcode reader, sample preparation tray, pipettes, and startup kit. | Advanced Instruments GloCyte® Automated Cell Counter System | ADVANCED INSTRUMENTS, INC. |
36 | 00816068020016 | 806053 | 806053 | For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Pipette, 10µL Fixed For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Used for aspirating and dispensing sample and reagents. | Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume | ADVANCED INSTRUMENTS, INC. |
37 | 00816068020009 | 806054 | 806054 | For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Pipette, 30µL Fixed For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Used for aspirating and dispensing sample and reagents. | Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume | ADVANCED INSTRUMENTS, INC. |