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 | 00896863002257 | 1313-31 | 1313-31 | The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Ammonia Alcohol Control Level 3 Set 3x5mL | QUANTIMETRIX CORPORATION |
2 | 00896863002240 | 1312-31 | 1312-31 | The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Ammonia Alcohol Control Level 2 Set 3x5mL | QUANTIMETRIX CORPORATION |
3 | 00896863002233 | 1311-31 | 1311-31 | The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Ammonia Alcohol Control Level 1 Set 3x5mL | QUANTIMETRIX CORPORATION |
4 | 00896863002073 | 1450-01 | 1450-01 | The Dropper Spinal Fluid Control is intended as a means of monitoring spinal flu The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Spinal Fluid Control Level 1&2 Set 2x3mL | QUANTIMETRIX CORPORATION |
5 | 00896863002066 | 1510-02 | 1510-02 | The Dropper A1c Diabetes Control is intended for the quality control of analytic The Dropper A1c Diabetes Control is intended for the quality control of analytical procedures used to quantitate HbA1c. It is supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. It consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the methods indicated in the product insert. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth. | Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL | QUANTIMETRIX CORPORATION |
6 | 00896863002059 | 1290-01 | 1290-01 | The Complete D 25-OH Vitamin D control is intended to monitor the performance of The Complete D 25-OH Vitamin D control is intended to monitor the performance of clinical assays used to quantitate total 25-OH Vitamin D. It is supplied in two levels, 3mL per vial. Each kit contains 2 vials of level 1 and 2 vials of level 2 controls. The controls are liquid, ready to use and require no reconstitution of dilution. The controls are prepared in a human serum matrix fortified with analytes and preservatives. This control contains both 25-OH Vitamin D2 and D3, and when combined represent clinically relevant levels of Total Vitamin D. | Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL | QUANTIMETRIX CORPORATION |
7 | 00896863002011 | 1452-31 | 1452-31 | The Dropper Spinal Fluid Control is intended as a means of monitoring spinal flu The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Spinal Fluid Control Level 2 Set 3x3mL | QUANTIMETRIX CORPORATION |
8 | 00896863002004 | 1451-31 | 1451-31 | The Dropper Spinal Fluid Control is intended as a means of monitoring spinal flu The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Spinal Fluid Control Level 1 Set 3x3mL | QUANTIMETRIX CORPORATION |
9 | 00894046001608 | 005 | 005 | Advocate BMB Control Solutions High | Advocate BMB Control Solutions High | DIABETIC SUPPLY OF SUNCOAST, INC. |
10 | 00894046001585 | 003 | BMB003 | Advocate Control Solutions Level 1 Low 4 ml Bottle | Advocate Control Solutions Low | DIABETIC SUPPLY OF SUNCOAST, INC. |
11 | 00894030002871 | APX03AB0318 | Embrace TALK Control Solution L1 (LO) | OMNIS HEALTH, LLC | ||
12 | 00894030002864 | APX03AB0317 | Embrace TALK control solution L2 | Embrace TALK control solution HI | OMNIS HEALTH, LLC | |
13 | 00894030002826 | APX03AB0313HW | HealthWise Embrace TALK Blood Glucose Monitoring System (Starter Kit) | OMNIS HEALTH, LLC | ||
14 | 00894030002703 | APX02AB0510 | Embrace Control Solution Low | OMNIS HEALTH | ||
15 | 00894030002697 | APX02AB0511 | Embrace Control Solution Hi | OMNIS HEALTH | ||
16 | 00894030002680 | APX02AB0502 | Embrace 50ct Test Strip | OMNIS HEALTH | ||
17 | 00894030002666 | APX01AB0500VK | Embrace Value Kit (50ct Included) | OMNIS HEALTH | ||
18 | 00894030002611 | APX01AB0200N | Embrace Blood Glucose Monitor | OMNIS HEALTH, LLC | ||
19 | 00894030002581 | APX02GS0202RF | Embrace Gestational Diabetes Package - RETAIL (5 vials) | OMNIS HEALTH | ||
20 | 00894030002574 | APX02GS0202RF | Embrace Gestational Diabetes - Strips Refill Bundle (4 vials) | OMNIS HEALTH | ||
21 | 00894030002567 | APX01GS0200-L | Embrace Gestational Diabetes Package - LARGE (9 vials) | OMNIS HEALTH | ||
22 | 00894030002550 | APX01GS0200-S | Embrace Gestational Diabetes Package - SMALL (5 vials) | OMNIS HEALTH | ||
23 | 00894030002543 | APX01AGS0100-SR | EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials) | OMNIS HEALTH | ||
24 | 00894030002536 | APX01AK0200VK | Embrace Meter Value Pack (incl. 50ct) | OMNIS HEALTH | ||
25 | 00894030002482 | APX01GS0100-L | EmbraceEVO Gestational Diabetes Package - LARGE (9 vials) | OMNIS HEALTH | ||
26 | 00894030002475 | APX01GS0100-S | EmbraceEVO Gestational Diabetes Package - SMALL (5 vials) | OMNIS HEALTH | ||
27 | 00894030002420 | APX01AB0851 | Embrace EVO Mini Meter, all-in-one kit, RETAIL | OMNIS HEALTH | ||
28 | 00894030002413 | ALL02AB0210 | Embrace Pro Control Solution (L1/Normal; L2/High) | OMNIS HEALTH | ||
29 | 00894030002390 | ALL01AB0200 | Embrace Pro Meter | OMNIS HEALTH | ||
30 | 00894030002376 | APX02AB0811 | Embrace EVO Control Solution, L2 (Medium) | OMNIS HEALTH | ||
31 | 00894030002345 | APX02AB0810 | Embrace EVO Control Solution, L1 (Low) | OMNIS HEALTH | ||
32 | 00894030002260 | APX01AB0300 | Embrace Meter Kit (w/10 ct) | OMNIS HEALTH | ||
33 | 00894030002079 | APX02AB310 | Embrace Control Solution, L1 (Low) | OMNIS HEALTH | ||
34 | 00894030002062 | APX02AB0311 | Embrace Control Solution, L2 (High) | OMNIS HEALTH | ||
35 | 00894030002017 | APX01AB200 | Embrace Meter, Meter Only | OMNIS HEALTH | ||
36 | 00894030002000 | APX03AB0300 | Meter Only | Embrace TALK Blood Glucose Monitor | OMNIS HEALTH, LLC | |
37 | 00893038002371 | 98201 | 98201 | Alere Triage® BNP QC Controls | Alere Triage® | ALERE SAN DIEGO, INC. |
38 | 00891237001683 | GOD31 | 1683 | Blood glucose control solution for use with Easy Plus II blood glucose testing system | Easy Plus II Control Solution - HIGH | HOME AIDE DIAGNOSTICS, INC. |
39 | 00891237001676 | GOD11 | 1676 | Blood glucose control solution for use with Easy Plus II blood glucose testing system | Easy Plus II Control Solution - LOW | HOME AIDE DIAGNOSTICS, INC. |
40 | 00891237001522 | GOD31 | 1522 | Blood glucose control solution for use with Easy Talk blood glucose testing system | Easy Talk Control Solution - HIGH | HOME AIDE DIAGNOSTICS, INC. |
41 | 00891237001492 | GOD11 | 1492 | Blood glucose control solution for use with Easy Talk blood glucose testing system | Easy Talk Control Solution - LOW | HOME AIDE DIAGNOSTICS, INC. |
42 | 00891237001461 | 100040005 | 1461 | Blood glucose control solution for use with Trak blood glucose testing system | Easy Trak Control Solution - LOW | HOME AIDE DIAGNOSTICS, INC. |
43 | 00891237001454 | 100040006 | 1454 | Blood glucose control solution for use with Easy Trak blood glucose testing system | Easy Trak Control Solution - HIGH | HOME AIDE DIAGNOSTICS, INC. |
44 | 00891237001232 | T506-66 | 1232 | Blood glucose control solution for use with Easy Step blood glucose testing system | Easy Step Control Solution - HIGH | HOME AIDE DIAGNOSTICS, INC. |
45 | 00891237001225 | T506-65 | 1225 | Blood glucose control solution for use with Easy Step blood glucose testing system | Easy Step Control Solution - LOW | HOME AIDE DIAGNOSTICS, INC. |
46 | 00891237001201 | T506-64 | 1201 | Blood glucose control solution for use with Easy Step blood glucose testing system | Easy Step Control Solution - NORMAL | HOME AIDE DIAGNOSTICS, INC. |
47 | 00888277176747 | MPH5560 | MPH5560 | CNTRL, MINI, NORMAL, SINGLE PATIENT USE | Medline | MEDLINE INDUSTRIES, INC. |
48 | 00886338000055 | S5800397 | S5800397 | Level 1 | UASure II Uric Acid Control Solution L1 | APEX BIOTECHNOLOGY CORP. |
49 | 00885502016038 | IGM-0008 | IGMHI | EasyGluco™ High Control Solution | U.S. DIAGNOSTICS INC. | |
50 | 00885502016007 | IGM-0024 | INFINITY™ High Control Solution | U.S. DIAGNOSTICS INC. |