| 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 | 15099590701727 | C22529 | Total Immunoglobulin E (IgE) Reagent kit for AU/DxC AU clinical chemistry analyzers. | Total Immunoglobulin E (IgE) | BECKMAN COULTER, INC. | |
| 2 | 15099590227029 | 474620 | 474620 | IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent | IMMAGE | BECKMAN COULTER, INC. |
| 3 | 15099590221324 | 35000 | 35000 | The Access Total IgE assay is a paramagnetic particle, chemiluminescent immunoas The Access Total IgE assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative determination of total E (IgE) levels in human serum and plasma (heparin, EDTA) using the Access Immunoassay Systems. | Access Total IgE | BECKMAN COULTER, INC. |
| 4 | 15099590221317 | 35005 | 35005 | The Access Total IgE Calibrators are intended to calibrate the Access Total IgE The Access Total IgE Calibrators are intended to calibrate the Access Total IgE assay for the quantitative determination of total IgE levels in human serum and plasma (heparin, EDTA) using the Access Immunoassay Systems. | Access Total IgE Calibrators | BECKMAN COULTER, INC. |
| 5 | 15099590221300 | 35006 | 35006 | The Access Total IgE Calibrator S0 is intended for use with the Access Total IgE The Access Total IgE Calibrator S0 is intended for use with the Access Total IgE assay to dilute patient samples containing analyte concentrations greater than the analyte specific S6 calibrator. | Access Total IgE Calibrator S0 | BECKMAN COULTER, INC. |
| 6 | 14560189210155 | N/A | ST AIA-PACK IgEII | TOSOH CORPORATION | ||
| 7 | 07333066019864 | 34-2325-42 | 34-2325-42 | ImmunoCAP Total IgE Conjugate 400 | ImmunoCAP Total IgE Conjugate 400 | PHADIA AB |
| 8 | 07333066019796 | 34-2274-81 | 34-2274-81 | ImmunoCAP Total IgE Calibrator Strip | ImmunoCAP Total IgE Calibrator Strip | PHADIA AB |
| 9 | 07333066019789 | 34-2274-51 | 34-2274-51 | ImmunoCAP Total IgE Curve Control Strip | ImmunoCAP Total IgE Curve Control Strip | PHADIA AB |
| 10 | 07333066019772 | 34-2272-22 | 34-2272-22 | ImmunoCAP Total IgE Conjugate 100 | ImmunoCAP Total IgE Conjugate 100 | PHADIA AB |
| 11 | 07333066019673 | 10-9517-02 | 10-9517-02 | Contains one bottle of Total IgE Conjugate and four vials of each Total IgE Curv Contains one bottle of Total IgE Conjugate and four vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method. | ImmunoCAP Total IgE | PHADIA AB |
| 12 | 07333066019642 | 10-9447-01 | 10-9447-01 | Contains two vials of each Total IgE Control (L, M, H) for the ImmunoCAP Total IgE method. | ImmunoCAP Total IgE Control LMH | PHADIA AB |
| 13 | 07333066019529 | 10-9257-01 | 10-9257-01 | Contains three vials of each Total IgE Curve Control (CC-1, CC-2) for the Immuno Contains three vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method. | ImmunoCAP Total IgE Curve Controls | PHADIA AB |
| 14 | 07333066019512 | 10-9252-01 | 10-9252-01 | Contains one vial of each Total IgE Calibrator (Cal-2, Cal-10, Cal-50, Cal-200, Contains one vial of each Total IgE Calibrator (Cal-2, Cal-10, Cal-50, Cal-200, Cal-1000, Cal-5000) to form a complete calibration curve for the ImmunoCAP Total IgE method. | ImmunoCAP Total IgE Calibrators | PHADIA AB |
| 15 | 07333066011660 | 34-2275-01 | 34-2275-01 | ImmunoCAP IgE/ECP/Tryptase Sample Diluent | ImmunoCAP IgE/ECP/Tryptase Sample Diluent | PHADIA AB |
| 16 | 07333066011356 | 34-2264-51 | 34-2264-51 | ImmunoCAP IgE/ECP/Tryptase Sample Diluent | ImmunoCAP IgE/ECP/Tryptase Sample Diluent | PHADIA AB |
| 17 | 07333066004037 | 14-4509-01 | 14-4509-01 | ImmunoCAP Total IgE Anti-IgE | ImmunoCAP Total IgE Anti-IgE | PHADIA AB |
| 18 | 05055273203929 | IE7308 | IE7308 | An IgE test system is a device intended for the quantitative in vitro determinat An IgE test system is a device intended for the quantitative in vitro determination of immunoglobulin E (IgE) concentration in human serum or plasma | IgE | RANDOX LABORATORIES LIMITED |
| 19 | 05055273203912 | IE2492 | IE2492 | This product is intended for in vitro diagnostic use in the quality control of I This product is intended for in vitro diagnostic use in the quality control of IgE on clinical chemistry systems. | IgE CAL SET | RANDOX LABORATORIES LIMITED |
| 20 | 05051700010122 | PX014 | Sheep Anti-Human IgE Immunofixation Grade | THE BINDING SITE GROUP LIMITED | ||
| 21 | 04560189211087 | N/A | AIA-PACK IgEII Sample Diluting Solution | TOSOH CORPORATION | ||
| 22 | 04560189211070 | N/A | AIA-PACK IgEII Calibrator Set | TOSOH CORPORATION | ||
| 23 | 00850392007350 | BC-1035 | BC-1035 | BioCheck IgE EIA Test Kit is intended for the quantitative determination of immu BioCheck IgE EIA Test Kit is intended for the quantitative determination of immunoglobulin E (IgE) in human serum. | BioCheck IgE EIA Test Kit | BIOCHECK, INC. |
| 24 | 00842768008078 | 10446129 | OQTG15 | Quantitative determination of IgE in human serum and plasma on BN Systems | N Latex IgE mono | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 25 | 00842768006173 | 10445902 | K7054 | For the quantitative measurement of immunoglobulin E in human serum and plasma ( For the quantitative measurement of immunoglobulin E in human serum and plasma (heparin or EDTA) on the Dimension Vista® System | DImension Vista® Immunoglobulin E Flex® reagent cartridge | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 26 | 00840239017888 | EIA-1788 | EIA-1788 | The DRG IgE ELISA is intended for the quantitative determination of immunoglobul The DRG IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients. | Immunoglobulin E (IgE) ELISA | DRG INTERNATIONAL INC |
| 27 | 00816879022285 | 74120 | Hytec Specific/Total IgE Control | HYCOR BIOMEDICAL LLC | ||
| 28 | 00816879022063 | 71207 | SPECIFIC IGE CONTROL KIT | HYCOR BIOMEDICAL LLC | ||
| 29 | 00816879022018 | G011 | 743410 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Brome Grass Bromus inermis | HYCOR BIOMEDICAL LLC |
| 30 | 00816879021998 | T032 | 74948 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Willow, Black Salix nigra | HYCOR BIOMEDICAL LLC |
| 31 | 00816879021981 | T016 | 74947 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Pine, White Pinus strobus | HYCOR BIOMEDICAL LLC |
| 32 | 00816879021943 | W008 | 74940 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Dandelion Taraxacum officinale | HYCOR BIOMEDICAL LLC |
| 33 | 00816879021936 | W003 | 74939 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Ragweed, Giant Ambrosia trifida | HYCOR BIOMEDICAL LLC |
| 34 | 00816879021868 | F006 | 74639 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Barley Hordeum vulgare | HYCOR BIOMEDICAL LLC |
| 35 | 00816879021844 | W004 | 74472 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Ragweed, False Franseria acanthicarpa | HYCOR BIOMEDICAL LLC |
| 36 | 00816879021837 | I100 | 74467 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Cockroach (Americana) Periplaneta americana | HYCOR BIOMEDICAL LLC |
| 37 | 00816879021813 | W002 | 74449 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Ragweed, Western Ambrosia psilostachya | HYCOR BIOMEDICAL LLC |
| 38 | 00816879021806 | W005 | 744446 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Wormwood/Sagebrush Artemisia absinthium | HYCOR BIOMEDICAL LLC |
| 39 | 00816879021776 | W016 | 74436 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Marsh Elder, Rough Iva ciliata | HYCOR BIOMEDICAL LLC |
| 40 | 00816879021769 | W011 | 74434 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Thistle, Russian Salsola kali | HYCOR BIOMEDICAL LLC |
| 41 | 00816879021752 | W010 | 74433 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Lamb's Quarter (Goosefeet) Chenopodium album | HYCOR BIOMEDICAL LLC |
| 42 | 00816879021738 | W006 | 74431 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Mugwort Artemisia vulgaris | HYCOR BIOMEDICAL LLC |
| 43 | 00816879021691 | T009 | 74425 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Olive Tree Olea europaea | HYCOR BIOMEDICAL LLC |
| 44 | 00816879021653 | T061 | 74412 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Sycamore Platanus occidentalis | HYCOR BIOMEDICAL LLC |
| 45 | 00816879021622 | T006 | 74409 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Cedar, Mountain (Savin) Juniperus sabinoides (syn. Sabina,ashei) | HYCOR BIOMEDICAL LLC |
| 46 | 00816879021561 | M004 | 74386 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Mucor racemosus | HYCOR BIOMEDICAL LLC |
| 47 | 00816879021547 | M002 | 74384 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Cladosporium herbarum | HYCOR BIOMEDICAL LLC |
| 48 | 00816879021523 | G014 | 74340 | Avena sativa | Oat Pollen, Cultivated Avena sativa | HYCOR BIOMEDICAL LLC |
| 49 | 00816879021509 | G013 | 74338 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Velvet Grass Holcus lanatus | HYCOR BIOMEDICAL LLC |
| 50 | 00816879021479 | G015 | 74335 | A substance or reactant intended to be used together with a parent IVD to perfor A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. | Wheat Pollen, Cultivated Triticum aestivum | HYCOR BIOMEDICAL LLC |