| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00842768039416 | 10873440 | B4265-37 | For coagulation tests and as a rinsing solution for the sample needles of the Sy For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems | KQJ | SYSTEM, FIBRINOGEN DETERMINATION | Dade® CA System Buffer | |
| 2 | 00842768028441 | 10385332 | LKPM | For use in daily maintenance of the IMMULITE® and IMMULITE® 1000 systems | JJQ | COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE | 1 | IMMULITE® Probe Cleaning Kit |
| 3 | 00842768028427 | 10385231 | L2PWSM | For use in the routine operation of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers | JJQ | COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE | IMMULITE 2000/XPi Probe Wash Module | |
| 4 | 00842768017872 | 10446691 | OWZG23 | Quantitative determination of fibrinogen in plasma | KQJ | SYSTEM, FIBRINOGEN DETERMINATION | Multifibren® U | |
| 5 | 00842768017865 | 10446689 | OWZG19 | Quantitative determination of fibrinogen in plasma | KQJ | SYSTEM, FIBRINOGEN DETERMINATION | Multifibren® U | |
| 6 | 00842768017087 | 10873532 | OPOD05 | For quality control of the INNOVANCE® Heparin assay | GGN | Plasma, coagulation control | INNOVANCE Heparin UF Control 2 | |
| 7 | 00842768016134 | 10446085 | OQIO19 | N/T Protein Control SL/M is a medium level, multi-analyte control for use as acc N/T Protein Control SL/M is a medium level, multi-analyte control for use as accuracy and precision control in the determination of human serum proteins by immunonephelometry with the BN Systems | JJY | Multi-analyte controls, all kinds (assayed) | N/T Protein Control SL/M | |
| 8 | 00842768016110 | 10446089 | OQIP19 | N/T Protein Control SL/H is a high level, multi-analyte control for use as accur N/T Protein Control SL/H is a high level, multi-analyte control for use as accuracy and precision control in the determination of human serum proteins by immunonephelometry with the BN Systems | JJY | Multi-analyte controls, all kinds (assayed) | N/T Protein Control SL/H | |
| 9 | 00842768013065 | 10446632 | OWMG15 | Quantitative determination of thrombin/antithrombin III complex (TAT) in human plasma | JBQ | ANTITHROMBIN III QUANTITATION | 2 | Enzygnost® TAT micro |
| 10 | 00842768012945 | 10446620 | OWLD11 | Determination of heparin activity in plasma and for the monitoring of heparin therapy | KFF | ASSAY, HEPARIN | 2 | Berichrom® Heparin |
| 11 | 00842768011030 | 10446415 | OTXY13 | For the determination of the activity of coagulation factor X in human plasma by For the determination of the activity of coagulation factor X in human plasma by coagulometric methods | GJT | PLASMA, COAGULATION FACTOR DEFICIENT | Coagulation Factor X Deficient Plasma | |
| 12 | 00842768009976 | 10446316 | OSDF13 | For the determination of the activity of coagulation factor XI in human plasma b For the determination of the activity of coagulation factor XI in human plasma by coagulometric methods | GJT | PLASMA, COAGULATION FACTOR DEFICIENT | Coagulation Factor XI Deficient Plasma | |
| 13 | 00842768009761 | 10446295 | OSAR19 | Quantitative determination of IgA in human serum and plasma on BN Systems | CFN | METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) | 2 | N Antisera to Human IgA |
| 14 | 00842768009747 | 10446293 | OSAR11 | Quantitative determination of IgA in human serum and plasma on BN Systems | CFN | METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) | 2 | N Antisera to Human IgA |
| 15 | 00842768008153 | 10446136 | OQUB21 | Cleaning solution BN II, BN ProSpec® Systems and BCS® Systems | JZW | NEPHELOMETER | Cleaner SCS | |
| 16 | 00842768008054 | 10446127 | OQTC11 | Quantitative determination of soluble transferrin receptor (sTfR) in human serum Quantitative determination of soluble transferrin receptor (sTfR) in human serum and heparinized plasma on BN Systems | DDG | TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL | N Latex sTfR | |
| 17 | 00842768007477 | 10461887 | OQGP15 | LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lu LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants | GIR | REAGENT, RUSSEL VIPER VENOM | LA 1 Screening Reagent | |
| 18 | 00842768007279 | 10446043 | OQDC13 | Assayed control for RF ASL and CRP assays on Siemens Systems | JJY | Multi-analyte controls, all kinds (assayed) | N/T Rheumatology Control SL/2 | |
| 19 | 00842768006876 | 10445990 | OPCD03 | For use as a low level assayed control for the quantitative measurement of low m For use as a low level assayed control for the quantitative measurement of low molecular weight heparin with Berichrom Heparin | GIZ | PLASMA, CONTROL, NORMAL | Berichrom® Heparin LMW Control 1 | |
| 20 | 00842768006845 | 10445987 | OPCA03 | For calibration of the Berichrom Heparin assay for measurement of low molecular For calibration of the Berichrom Heparin assay for measurement of low molecular weight heparin | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Berichrom® Heparin LMW Calibrator | |
| 21 | 00842768006838 | 10445986 | OPBZ03 | For use as a high level assayed control for the quantitative measurement of unfr For use as a high level assayed control for the quantitative measurement of unfractionated heparin with Berichrom Heparin | GGC | CONTROL, PLASMA, ABNORMAL | Berichrom® Heparin UF Control 2 | |
| 22 | 00842768006715 | 10445973 | OPAX03 | Quantitative determination of homocysteine in human serum and plasma on BN II an Quantitative determination of homocysteine in human serum and plasma on BN II and BN ProSpec® Systems | LPS | URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM | 2 | N Latex HCY |
| 23 | 00842768006388 | 10445924 | KC735 | CYSC CON L is an assayed intralaboratory quality control for assessment of preci CYSC CON L is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of the CYSC method on the Dimension Vista® System | JJY | Multi-analyte controls, all kinds (assayed) | DImension Vista® Cystatin C Control L (low) | |
| 24 | 00842768006340 | 10445920 | KC716 | PROT1 CON M is an assayed, mid-level, intralaboratory, multi-analyte quality con PROT1 CON M is an assayed, mid-level, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System | JJY | Multi-analyte controls, all kinds (assayed) | DImension Vista® Protein 1 Control M (medium) | |
| 25 | 00842768004056 | 10445731 | B4244-10 | For use as control in citrated coagulation systems | GGC | CONTROL, PLASMA, ABNORMAL | Dade® Ci-Trol® Coagulation Control Level 1 | |
| 26 | 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 | DGC | IGE, ANTIGEN, ANTISERUM, CONTROL | DImension Vista® Immunoglobulin E Flex® reagent cartridge | |
| 27 | 00842768006135 | 10445898 | K7046 | For the quantitative measurement of C-reactive protein in human serum and plasma For the quantitative measurement of C-reactive protein in human serum and plasma on the Dimension Vista® System | NQD | CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL | Dimension Vista hsCRP Flex reagent cartridge | |
| 28 | 00842768006128 | 10445897 | K7044 | For the quantitative measurement of total homocysteine in human serum and plasma For the quantitative measurement of total homocysteine in human serum and plasma on the Dimension Vista® System | LPS | URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM | DImension Vista® Homocysteine Flex® reagent cartridge | |
| 29 | 00842768003967 | 10445722 | B4233-60 | The DIMERTEST® Latex Assay is intended for the rapid qualitative or semiquantita The DIMERTEST® Latex Assay is intended for the rapid qualitative or semiquantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (XL-FDP) in human plasma | DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | Dade® DIMERTEST® Latex Assay |
| 30 | 00842768003929 | 10445718 | B4233-15SY | Quantitative determination of fibrinogen in human plasma | GFK | FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS | 2 | Dade® Fibrinogen Determination Reagents |
| 31 | 00842768003905 | 10445716 | B4224-60 | Control in heparin assay procedures | KFF | ASSAY, HEPARIN | Dade® Ci-Trol® Heparin Control, High | |
| 32 | 00842768003899 | 10445715 | B4224-50 | Control in heparin assay procedures | KFF | ASSAY, HEPARIN | Dade® Ci-Trol® Heparin Control, Low | |
| 33 | 00630414992617 | 10459382 | B4132-1A | For differential staining in hematology that gives results similar to a Wright-G For differential staining in hematology that gives results similar to a Wright-Giemsa stain | KQC | STAINS, HEMATOLOGY | 1 | Diff-Quik™ Stain Set |
| 34 | 00630414285054 | 10873691 | OWTI15 | Quantitative determination of ADNase B in human serum on BN Systems | GTR | ANTIDEOXYRIBONUCLEASE, STREPTOCOCCUS SPP. | 1 | N Latex ADNase B (USA) |
| 35 | 00630414284996 | 10873685 | OQDC17 | Assayed control for RF, ASL and CRP assays on BN Systems | JJY | Multi-analyte controls, all kinds (assayed) | 1 | N/T Rheumatology Control SL/2 |
| 36 | 00630414237503 | 10873663 | OPJF05 | Assayed accuracy and precision controls in the determination of free light chain Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems. | JJY | Multi-analyte controls, all kinds (assayed) | N FLC CONTROL SL2 | |
| 37 | 00630414237480 | 10873661 | OPJE05 | Assayed accuracy and precision controls in the determination of free light chain Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems. | JJY | Multi-analyte controls, all kinds (assayed) | N FLC CONTROL SL1 | |
| 38 | 00630414023526 | 10873571 | B4233-17SY | Quantitative determination of fibrinogen in human plasma | GFK | FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS | 2 | Dade® Fibrinogen Determination Reagents |
| 39 | 00630414002736 | 10465217 | OVLI012 | The BN ProSpec® is a system for the quantitative determination of proteins in se The BN ProSpec® is a system for the quantitative determination of proteins in serum, plasma, urine and CSF | JZW | NEPHELOMETER | 1 | BN ProSpec® System |
| 40 | 00842768028410 | 10385393 | LPWS2 | For use in the routine operation of the IMMULITE® and IMMULITE® 1000 Analyzers | JJQ | COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE | IMMULITE® Probe Wash Module | |
| 41 | 00842768018534 | 10445997 | OPCS05 | Quantitative determination of carbohydrate-deficient transferrin (CDT) in human Quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum on BN II and BN ProSpec® Systems | NAO | Test,carbohydrate deficient transferrin | 1 | N Latex CDT Kit |
| 42 | 00842768014222 | 10446232 | ORHO37 | Supplementary Reagent for coagulation tests | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Calcium Chloride Solution | |
| 43 | 00842768013478 | 10446673 | OWWR17 | Determination of the functional activity of antithrombin III (AT III) in human plasma | JPE | ANTITHROMBIN III, TWO STAGE CLOTTING TIME ASSAY | 2 | Berichrom® Antithrombin III (A) |
| 44 | 00842768013461 | 10446672 | OWWR15 | Determination of the functional activity of antithrombin III (AT III) in human plasma | JPE | ANTITHROMBIN III, TWO STAGE CLOTTING TIME ASSAY | 2 | Berichrom® Antithrombin III (A) |
| 45 | 00842768012778 | 10446604 | OWHU21 | Qualitative detection or semi-quantitative determination of C-reactive protein ( Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum | DCN | SYSTEM, TEST, C-REACTIVE PROTEIN | 2 | RapiTex® CRP |
| 46 | 00842768012686 | 10446595 | OWHG13 | Quantitative determination of Ig light chains, type kappa in human serum on BN Systems | DFH | KAPPA, ANTIGEN, ANTISERUM, CONTROL | 2 | N Antiserum to Human-Ig/L-chain, K-type |
| 47 | 00842768012297 | 10446534 | OVLC21 | The N Evaporation Cap 2.5ml is part of the BN ProSpec system. | JZW | NEPHELOMETER | N Evaporation Caps for Control Vials (2.5 mL) | |
| 48 | 00842768012174 | 10446521 | OVIC11 | The N Predilution Well is used for settings of dilutions of standards, controls and sera. | DEW | IGG, ANTIGEN, ANTISERUM, CONTROL | N Predilution Wells | |
| 49 | 00842768011443 | 10446458 | OUMU15 | Supplementary reagent for multiple protein assays on Siemens systems | CFN | METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) | 2 | N Supplementary Reagent/Precipitation |
| 50 | 00842768011085 | 10446420 | OUAX41 | Qualitative detection or semi-quantitative determination of C-reactive protein ( Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum | DCN | SYSTEM, TEST, C-REACTIVE PROTEIN | 2 | RapiTex® CRP |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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. |
| 2 | 00842768008078 | 10446129 | OQTG15 | Quantitative determination of IgE in human serum and plasma on BN Systems | N Latex IgE mono | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 3 | 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 |
| 4 | 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 |
| 5 | 00816879022285 | 74120 | Hytec Specific/Total IgE Control | HYCOR BIOMEDICAL LLC | ||
| 6 | 00816879022063 | 71207 | SPECIFIC IGE CONTROL KIT | HYCOR BIOMEDICAL LLC | ||
| 7 | 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 |
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |
| 16 | 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 |
| 17 | 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 |
| 18 | 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 |
| 19 | 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 |
| 20 | 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 |
| 21 | 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 |
| 22 | 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 |
| 23 | 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 |
| 24 | 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 |
| 25 | 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 |
| 26 | 00816879021523 | G014 | 74340 | Avena sativa | Oat Pollen, Cultivated Avena sativa | HYCOR BIOMEDICAL LLC |
| 27 | 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 |
| 28 | 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 |
| 29 | 00816879021462 | G003 | 74333 | 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. | Orchard Grass Dactylis glomerata | HYCOR BIOMEDICAL LLC |
| 30 | 00816879021455 | G017 | 74331 | 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. | Bahia Grass Paspalum notatum | HYCOR BIOMEDICAL LLC |
| 31 | 00816879021448 | G010 | 74330 | 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. | Johnson Grass Sorghum halepense | HYCOR BIOMEDICAL LLC |
| 32 | 00816879021394 | G009 | 74323 | 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. | Red Top | HYCOR BIOMEDICAL LLC |
| 33 | 00816879021356 | F005 | 74283 | 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. | Rye | HYCOR BIOMEDICAL LLC |
| 34 | 00816879021349 | F020 | 74273 | 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. | Almond | HYCOR BIOMEDICAL LLC |
| 35 | 00816879021325 | F040 | 74269 | 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. | Tuna | HYCOR BIOMEDICAL LLC |
| 36 | 00816879021301 | F081 | 74267 | 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. | Cheddar Cheese | HYCOR BIOMEDICAL LLC |
| 37 | 00816879021295 | F026 | 74266 | 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. | Pork | HYCOR BIOMEDICAL LLC |
| 38 | 00816879021288 | F009 | 74265 | 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. | Rice | HYCOR BIOMEDICAL LLC |
| 39 | 00816879021264 | F035 | 74248 | 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. | Potato, White | HYCOR BIOMEDICAL LLC |
| 40 | 00816879021257 | F033 | 74247 | 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. | Orange | HYCOR BIOMEDICAL LLC |
| 41 | 00816879021240 | F025 | 74245 | 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. | Tomato | HYCOR BIOMEDICAL LLC |
| 42 | 00816879021233 | F014 | 74241 | 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. | Soybean | HYCOR BIOMEDICAL LLC |
| 43 | 00816879021226 | F013 | 74240 | 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. | Peanut | HYCOR BIOMEDICAL LLC |
| 44 | 00816879021219 | F008 | 74239 | Corn | Corn | HYCOR BIOMEDICAL LLC |
| 45 | 00816879021165 | E004 | 74220 | 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. | Customerservices-us@hycorbiomedical.com | HYCOR BIOMEDICAL LLC |
| 46 | 00816879021158 | E003 | 74219 | 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. | Horse Dander | HYCOR BIOMEDICAL LLC |
| 47 | 00816870021959 | 2575-300 | 2575-300E | Monobind AccuLite IgE CLIA Kit - 960 Wells | MONOBIND, INC. | |
| 48 | 00816870021942 | 2575-300 | 2575-300D | Monobind AccuLite IgE CLIA Kit - 480 Wells | MONOBIND, INC. | |
| 49 | 00816870021935 | 2575-300 | 2575-300B | Monobind AccuLite IgE CLIA Kit - 192 Wells | MONOBIND, INC. | |
| 50 | 00816870021928 | 2575-300 | 2575-300A | Monobind AccuLite IgE CLIA Kit - 96 Wells | MONOBIND, INC. |