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 | 00811727016225 | 16-L7597-160 | 16-L7597-160 | Pointe Lp(a) Reagent packaged for use on the Mindray BA800. 2 x 60ml R1, 2 x 2 Pointe Lp(a) Reagent packaged for use on the Mindray BA800. 2 x 60ml R1, 2 x 20ml R2. The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests. | Pointe Lp(a) Reagent | POINTE SCIENTIFIC, INC. |
2 | 00811727015921 | 14-L7597-216 | 14-L7597-216 | Pointe Lp(a) Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 x 14m Pointe Lp(a) Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 x 14ml R2. The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests. | Pointe Lp(a) Reagent | POINTE SCIENTIFIC, INC. |
3 | 00811727011831 | L7597-CAL | L7597-CAL | Pointe Scientific, Inc. Lipoprotein (a) Calibrator Set for in vitro use only. T Pointe Scientific, Inc. Lipoprotein (a) Calibrator Set for in vitro use only. This five level calibrator set is intended for use in the quantitative determination of Lp(a) in human serum by immunoturbidimetric analysis. | Pointe Scientific, Inc. Lipoprotein (a) | POINTE SCIENTIFIC, INC. |
4 | 00811727011824 | L7597-40 | L7597-40 | Pointe Scientific, Inc. Lipoprotein (a) Reagent is an in vitro diagnostic test f Pointe Scientific, Inc. Lipoprotein (a) Reagent is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples.1 x 30 ml, 1 x 10 ml | Pointe Scientific, Inc. Lipoprotein (a) | POINTE SCIENTIFIC, INC. |
5 | 00630414595559 | 11097627 | 11097627 | Lipoprotein A (LP(a)) Atellica CH - RGT 400T | Atellica CH Lp(a) | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
6 | 00380740175146 | 9D93-22 | 09D9322 | Apolipoprotein B | ARCHITECT | ABBOTT GMBH |
7 | 00380740170165 | 09D9324 | 09D9324 | Apolipoprotein B 243 tests | ARCHITECT | ABBOTT IRELAND |
8 | 00380740170158 | 09P4724 | 09P4724 | Apolipoprotein B 190 Tests | Alinity | ABBOTT IRELAND |
9 | 00380740156435 | 07K0041 | 07K0041 | Quantia Lipoprotein(a) | ARCHITECT | ABBOTT LABORATORIES |
10 | 00380740154509 | 09P4720 | 09P4720 | Alinity c Apolipoprotein B Reagent Kit 190 Tests | Alinity | ABBOTT GMBH |
11 | 00380740153847 | 01R1421 | 01R1421 | Alinity c Lp(a) Reagent Kit 200 Tests | Alinity | ABBOTT LABORATORIES |
12 | 00380740054267 | 7K00-40 | 07K0040 | Quantia Lipoprotein(a) | ARCHITECT | ABBOTT LABORATORIES |
13 | 00380740019723 | 9D93-21 | 09D9321 | Apolipoprotein B | ARCHITECT | ABBOTT LABORATORIES |
14 | 15099590221171 | 447450 | 447450 | IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent | IMMAGE | BECKMAN COULTER, INC. |
15 | M2045020010 | 502-001 | 502-001 | TorqMax™ Sheath Grip Assembly | TorqMax™ | SPECTRANETICS CORPORATION |
16 | 07613336140833 | 08106126190 | 08106126190 | Tina-quant Lipoprotein (a) Gen.2 | ROCHE DIAGNOSTICS GMBH | |
17 | 07613336133538 | 08105464190 | 08105464190 | Tina-quant Apolipoprotein B ver.2 | ROCHE DIAGNOSTICS GMBH | |
18 | 05391516743938 | 2339100 | 2339100 | Macra® Lp(a) | Trinity Biotech | CLARK LABORATORIES, INC. |
19 | 05055845400022 | FHCY200 | FHCY200 | The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed qu The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or plasma. | Axis-Shield Homocysteine Controls | AXIS-SHIELD DIAGNOSTICS LIMITED |
20 | 05055845400015 | FHCY100 | FHCY100 | The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. | Axis® Homocysteine EIA | AXIS-SHIELD DIAGNOSTICS LIMITED |
21 | 05055273209198 | LP2757 | LP2757 | Immunoturbidimetric assay for the quantitative in vitro determination of Lipopro Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma. | Lp (a) | RANDOX LABORATORIES LIMITED |
22 | 05055273204445 | LP3406 | Randox Lipoprotein(a) level 3 control is based on lyophilised human serum contai Randox Lipoprotein(a) level 3 control is based on lyophilised human serum containing Lipoprotein(a). | LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) | RANDOX LABORATORIES LIMITED | |
23 | 05055273204421 | LP3403 | LP3403 | Immunoturbidimetric assay for the quantitative in vitro determination of Lipopro Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma. | Lp (a) | RANDOX LABORATORIES LIMITED |
24 | 05055273204384 | LP2878 | LP2878 | For the quantitative in vitro determination of Lipoprotein (a) in human serum or plasma. | Lp (a) | RANDOX LABORATORIES LIMITED |
25 | 05051700016841 | LK098.S | Lipoprotein (a) Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | ||
26 | 04015630930586 | 5852633190 | 5852633190 | Tinaquant Lipoprotein a Gen.2 | ROCHE DIAGNOSTICS GMBH | |
27 | 04015630930234 | 6301711190 | 6301711190 | Tinaquant Apolipoprotein B ver2 | ROCHE DIAGNOSTICS GMBH | |
28 | 04015630929962 | 5852625190 | 5852625190 | Tinaquant Lipoprotein a Gen.2 | ROCHE DIAGNOSTICS GMBH | |
29 | 04015630928668 | 5950694190 | 5950694190 | Tinaquant Apolipoprotein B ver2 | ROCHE DIAGNOSTICS GMBH | |
30 | 04015630917754 | 3032639122 | 3032639122 | Tinaquant Apolipoprotein B ver2 | ROCHE DIAGNOSTICS GMBH | |
31 | 04015630917730 | 3032574122 | 3032574122 | Tinaquant Apolipoprotein B ver2 | ROCHE DIAGNOSTICS GMBH | |
32 | 00842768007552 | 10446069 | OQHL11 | Quantitative determination of Lp(a) in human serum and heparinized plasma on BN Systems | N Latex Lp(a) Reagent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
33 | 00817439021090 | LPAC480 | LPAC480 | Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calib Lipoprotein(a) calibrator series is an in vitro diagnostic product for the calibration of Lipoprotein(a). 5 x 1 ml. | MedTest DX Lipoprotein (a) Calibrator for the BS480 | MEDTEST DX, INC. |
34 | 00817439021069 | LPA480 | LPA480 | The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determ The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples on the Mindray BS-480. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.4 x 40 ml, 4 x 14 ml | MedTest Dx, Inc. Lp (a) | MEDTEST DX, INC. |
35 | 00817302022315 | BL-204B | BL-204B | Lp (a) Lipoprotein BL-204B | CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit | CAROLINA LIQUID CHEMISTRIES CORPORATION |
36 | 00817302022308 | AU-204B | AU-204B | Lp (a) Lipoprotein AU-204B | CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit | CAROLINA LIQUID CHEMISTRIES CORPORATION |
37 | 00817302020151 | CC204-100-D | CC204-100-D | Lp(a) (Lipoprotein (a) 2 x 60 tests | CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D | CAROLINA LIQUID CHEMISTRIES CORPORATION |
38 | 00817302020144 | AU-204-D | AU-204-D | Lp(a) (Lipoprotein (a) 3 x 400 tests | CAROLINA LIQUID CHEMISTRIES CORP.® LP(a)-D RGT. KIT AU-204-D | CAROLINA LIQUID CHEMISTRIES CORPORATION |
39 | 00817302020137 | BL204 | BL204 | Lp(a) (Lipoprotein (a) 2 x 130 tests | CAROLINA LIQUID CHEMISTRIES CORP.® LP(a) RGT. KIT BL-204 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
40 | 00816426020979 | K114C-4M | K114C-4M | For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for lipoprotein(a) [Lp(a)]. | K-ASSAY® Lp(a) Control | KAMIYA BIOMEDICAL COMPANY, LLC |
41 | 00816426020962 | K114C-2M | K114C-2M | For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for lipoprotein(a) [Lp(a)]. | K-ASSAY® Lp(a) Control | KAMIYA BIOMEDICAL COMPANY, LLC |
42 | 00816426020245 | KAI-044 | KAI-044 | For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by i For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay. | K-ASSAY® Lp(a) Reagent | KAMIYA BIOMEDICAL COMPANY, LLC |
43 | 00816426020122 | KAI-017 | KAI-017 | For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by i For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay. | K-ASSAY® Lp(a) Reagent (L) | KAMIYA BIOMEDICAL COMPANY, LLC |
44 | 00813132020446 | 502-001AA | 502-001 | TorqMax™ Sheath Grip Assembly | TorqMax™ | SPECTRANETICS CORPORATION |