| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00816879026337 | F282 | 746870 | MVU | Reagents, Specific, Analyte | 1 | Nutmeg, Myristica fragrans | |
| 2 | 00816879026313 | F280 | 74290 | MVU | Reagents, Specific, Analyte | 1 | Black Pepper, Piper nigrum | |
| 3 | 00816879026214 | F214 | 74581 | MVU | Reagents, Specific, Analyte | 1 | Spinach, Spinacia oleracea | |
| 4 | 00816879026146 | F95 | 74657 | MVU | Reagents, Specific, Analyte | 1 | Peach, Prunus persica | |
| 5 | 00816879026092 | F53 | 742680 | MVU | Reagents, Specific, Analyte | 1 | Scallop | |
| 6 | 00816879026078 | F242 | 743210 | MVU | Reagents, Specific, Analyte | 1 | Bing Cherry, Prunus avium | |
| 7 | 00816879026061 | W45 | 745050 | MVU | Reagents, Specific, Analyte | 1 | Alfalfa, Medicago sativa | |
| 8 | 00816879026047 | F139 | 745790 | MVU | Reagents, Specific, Analyte | 1 | Goat's Cheese | |
| 9 | 00816879025941 | F119 | 746170 | MVU | Reagents, Specific, Analyte | 1 | Radish, Raphanus sativus | |
| 10 | 00816879025743 | F236 | 741640 | MVU | Reagents, Specific, Analyte | 1 | Whey | |
| 11 | 00816879025699 | F212 | 742990 | MVU | Reagents, Specific, Analyte | 1 | Mushroom, Agaricus hortensis/bisporus | |
| 12 | 00816879025668 | F183 | 745690 | MVU | Reagents, Specific, Analyte | 1 | Sunflower Seed | |
| 13 | 00816879025606 | W18 | 74479 | MVU | Reagents, Specific, Analyte | 1 | Sheep Sorrel, Red Rumex acetosella | |
| 14 | 00816879025583 | F290 | 742550 | MVU | Reagents, Specific, Analyte | 1 | Oyster, Ostrea sp. | |
| 15 | 00816879025538 | F218 | 746880 | MVU | Reagents, Specific, Analyte | 1 | Paprika, Capsicum annuum | |
| 16 | 00816879023596 | G006 | 63283 | DHB,JJE | System, Test, Radioallergosorbent (Rast) Immunological,Analyzer, Chemistry (Phot System, Test, Radioallergosorbent (Rast) Immunological,Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | NOVEOS Timothy Grass, Phleum pratense | |
| 17 | 00816879023510 | D002 | 63208 | DHB,JJE | System, Test, Radioallergosorbent (Rast) Immunological,Analyzer, Chemistry (Phot System, Test, Radioallergosorbent (Rast) Immunological,Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | NOVEOS House Dust Mite, Dermatophagoides farinae | |
| 18 | 00816879023312 | I5 | 748440 | MVU | Reagents, Specific, Analyte | 1 | Yellow Hornet, Dolichovespula arenaria | |
| 19 | 00816879023008 | 63140 | DHB,JJE | System, Test, Radioallergosorbent (Rast) Immunological,Analyzer, Chemistry (Phot System, Test, Radioallergosorbent (Rast) Immunological,Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | NOVEOS IgE Common Kit | ||
| 20 | 00816879020243 | FGA24 | 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgA antibodies in human serum | MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 | Autostat II Anti-B2-Glycoprotein I IgA | |
| 21 | 00816879026351 | F234 | 746780 | MVU | Reagents, Specific, Analyte | 1 | Vanilla, Vanilla planifolia | |
| 22 | 00816879022315 | 288197 | 288197 | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Hytec Probe Cleaning Solution | |
| 23 | 00816879022223 | 309046 | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Total IgE Sample Diluent | ||
| 24 | 00816879022094 | 74129 | 74129 | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | IgE Extended Calibrator Set | |
| 25 | 00816879022025 | G016 | 743420 | 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. | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Foxtail, Meadow Alopecurus pratensis |
| 26 | 00816879021882 | M009 | 74746 | 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. | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Fusarium moniliforme |
| 27 | 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. | DGC | Ige, Antigen, Antiserum, Control | 2 | Marsh Elder, Rough Iva ciliata |
| 28 | 00816879021745 | W009 | 74432 | 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. | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Plantain, English Plantago lanceolata |
| 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. | DGC | Ige, Antigen, Antiserum, Control | 2 | Orchard Grass Dactylis glomerata |
| 30 | 00816879021400 | G002 | 74326 | 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. | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Bermuda Grass Cynodon dactylon |
| 31 | 00816879021202 | F007 | 74238 | 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. | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | Oat |
| 32 | 00816879021127 | D002 | 74202 | 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. | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | House dust Mite D. farinae |
| 33 | 00816879020656 | F182 | 749060 | MVU | Reagents, Specific, Analyte | 1 | Lima Bean, Phaseolus limensis | |
| 34 | 00816879020557 | F219 | 748760 | MVU | Reagents, Specific, Analyte | 1 | Sage, Salvia officinalis | |
| 35 | 00081687902221 | 308174 | DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | IgE Conjugate MCS | ||
| 36 | 00816879026276 | F90 | 74303 | MVU | Reagents, Specific, Analyte | 1 | Malt | |
| 37 | 00816879025460 | K80 | 747220 | MVU | Reagents, Specific, Analyte | 1 | Formaldehyde | |
| 38 | 00816879022988 | T12 | 749490 | MVU | Reagents, Specific, Analyte | 1 | Willow, Salix caprea | |
| 39 | 00816879026320 | F221 | 74280 | MVU | Reagents, Specific, Analyte | 1 | Coffee, Coffea spp. | |
| 40 | 00816879026269 | F315 | 74305 | MVU | Reagents, Specific, Analyte | 1 | Green Bean, Phaseolus vulgaris | |
| 41 | 00816879026245 | F260 | 74570 | MVU | Reagents, Specific, Analyte | 1 | Broccoli, Brassica oleracea var. botrytis | |
| 42 | 00816879025989 | F273 | 745980 | MVU | Reagents, Specific, Analyte | 1 | Thyme, Thymus vulgaris | |
| 43 | 00816879025965 | F179 | 746090 | MVU | Reagents, Specific, Analyte | 1 | Raisin, Vitis sp | |
| 44 | 00816879025927 | F118 | 746250 | MVU | Reagents, Specific, Analyte | 1 | Zucchini, Cucurbita pepo | |
| 45 | 00816879025880 | M202 | 74163 | MVU | Reagents, Specific, Analyte | 1 | Acremonium kiliense, syn. Acremonium strictum | |
| 46 | 00816879025798 | F284 | 74580 | MVU | Reagents, Specific, Analyte | 1 | Turkey, Meleagris gallopavo | |
| 47 | 00816879025774 | F208 | 74626 | MVU | Reagents, Specific, Analyte | 1 | Lemon, Citrus limon | |
| 48 | 00816879025712 | F225 | 742880 | MVU | Reagents, Specific, Analyte | 1 | Pumpkin/ Summer Squash, Cucurbita pepo | |
| 49 | 00816879025682 | F261 | 743110 | MVU | Reagents, Specific, Analyte | 1 | Asparagus, Asparagus officinalis | |
| 50 | 00816879023947 | G004 | 8632810 | PUW | System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | 2 | NOVEOS Capture Reagent Pack Meadow Fescue, Festuca elatior |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00816879023596 | G006 | 63283 | NOVEOS Timothy Grass, Phleum pratense | HYCOR BIOMEDICAL LLC | |
| 2 | 00816879023527 | E001 | 63212 | NOVEOS Cat Dander, Felis domesticus | HYCOR BIOMEDICAL LLC | |
| 3 | 00816879023510 | D002 | 63208 | NOVEOS House Dust Mite, Dermatophagoides farinae | HYCOR BIOMEDICAL LLC | |
| 4 | 00816879023503 | D001 | 63207 | NOVEOS House Dust Mite, Dermatophagoides pteronyssinus | HYCOR BIOMEDICAL LLC | |
| 5 | 00816879023169 | 63190 | NOVEOS Cuvette Wash Pack | HYCOR BIOMEDICAL LLC | ||
| 6 | 00816879023114 | 117450-001 | NOVEOS Cuvette Arc Pack | HYCOR BIOMEDICAL LLC | ||
| 7 | 00816879023107 | 119844-001 | NOVEOS Optics Tip Pack | HYCOR BIOMEDICAL LLC | ||
| 8 | 00816879023091 | 118877-001 | NOVEOS Substrate Mix Container Pack | HYCOR BIOMEDICAL LLC | ||
| 9 | 00816879023077 | 63180 | NOVEOS IgE Calibrator Antibody Pack | HYCOR BIOMEDICAL LLC | ||
| 10 | 00816879023053 | 63170 | NOVEOS Probe Wash Pack | HYCOR BIOMEDICAL LLC | ||
| 11 | 00816879023046 | 63165 | NOVEOS Wash Buffer Concentrate Pack | HYCOR BIOMEDICAL LLC | ||
| 12 | 00816879023039 | 63155 | NOVEOS IgE Negative Control Pack | HYCOR BIOMEDICAL LLC | ||
| 13 | 00816879023022 | 63150 | NOVEOS IgE Positive Control Pack | HYCOR BIOMEDICAL LLC | ||
| 14 | 00816879023015 | 63145 | NOVEOS IgE Calibrator Set | HYCOR BIOMEDICAL LLC | ||
| 15 | 00816879023008 | 63140 | NOVEOS IgE Common Kit | HYCOR BIOMEDICAL LLC | ||
| 16 | 00816879022995 | Immunoassay Analyzer | 63000 | The NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay an The NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay analyzer for measurement of analyte concentration in human specimens. It is intended for in vitro diagnostic use in the clinical laboratory. | NOVEOS | HYCOR BIOMEDICAL LLC |
| 17 | 00816879022865 | Maple/Box Elder | 74407 | Hytec | HYCOR BIOMEDICAL LLC | |
| 18 | 00816879022858 | MCS Specific Total IgE Conjugate | 308174 | HYTEC | HYCOR BIOMEDICAL LLC | |
| 19 | 00816879022841 | Specific IgE Reference Disc | 74112 | HYTEC | HYCOR BIOMEDICAL LLC | |
| 20 | 00816879022322 | 288-6002-350 | Hytec Automated EIA System for Total IgE and Specific IgE | HYCOR BIOMEDICAL LLC | ||
| 21 | 00816879022315 | 288197 | 288197 | Hytec Probe Cleaning Solution | HYCOR BIOMEDICAL LLC | |
| 22 | 00816879022308 | 74155 | Hytec EIA Kit | HYCOR BIOMEDICAL LLC | ||
| 23 | 00816879022292 | 74118 | IgE Reference Disc | HYCOR BIOMEDICAL LLC | ||
| 24 | 00816879022261 | 308053 | 74130 | Four vials per package. | PnPP Tablets | HYCOR BIOMEDICAL LLC |
| 25 | 00816879022247 | 308050 | Substrate Diluent | HYCOR BIOMEDICAL LLC | ||
| 26 | 00816879022223 | 309046 | Total IgE Sample Diluent | HYCOR BIOMEDICAL LLC | ||
| 27 | 00816879022216 | 308174 | 308174 | MCS Specific/Total IgE Conjugate | HYCOR BIOMEDICAL LLC | |
| 28 | 00816879022186 | 312500 | Tubes (9x45mm plastic) | HYCOR BIOMEDICAL LLC | ||
| 29 | 00816879022148 | 308126 | EIA Wash Solution | HYCOR BIOMEDICAL LLC | ||
| 30 | 00816879022131 | 308151 | 308151 | Stop Solution (Allergy) | HYCOR BIOMEDICAL LLC | |
| 31 | 00816879022100 | 74154 | 74154 | Hytec Specific/Total IgE EIA | HYCOR BIOMEDICAL LLC | |
| 32 | 00816879022094 | 74129 | 74129 | IgE Extended Calibrator Set | HYCOR BIOMEDICAL LLC | |
| 33 | 00816879022087 | 74119 | Specific IgE calibrator set | HYCOR BIOMEDICAL LLC | ||
| 34 | 00816879022070 | 74112 | 74112 | IgE Reference Discs | HYCOR BIOMEDICAL LLC | |
| 35 | 00816879022056 | T045 | 749740 | 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. | Elm, Fall Blooming/Scrub Ulmus crassifolia | HYCOR BIOMEDICAL LLC |
| 36 | 00816879022049 | T042 | 749720 | 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, Ponderosa Pinus ponderosa | HYCOR BIOMEDICAL LLC |
| 37 | 00816879022032 | W007 | 744470 | 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. | Oxeye Daisy Chrysanth. leucanthemum | HYCOR BIOMEDICAL LLC |
| 38 | 00816879022025 | G016 | 743420 | 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. | Foxtail, Meadow Alopecurus pratensis | HYCOR BIOMEDICAL LLC |
| 39 | 00816879022001 | G007 | 74982 | 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. | Reed, Common Phragmites communis | HYCOR BIOMEDICAL LLC |
| 40 | 00816879021974 | T015 | 74946 | 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. | Ash, White F. americana | HYCOR BIOMEDICAL LLC |
| 41 | 00816879021967 | T004 | 74944 | 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. | Hazelnut Corylus avellana | HYCOR BIOMEDICAL LLC |
| 42 | 00816879021950 | T020 | 74942 | 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. | Mesquite Prosopis glandulosa (juliflora) | HYCOR BIOMEDICAL LLC |
| 43 | 00816879021929 | M049 | 74784 | 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. | Fusarium oxysporum | HYCOR BIOMEDICAL LLC |
| 44 | 00816879021912 | M046 | 74752 | 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. | Bipolaris spicifera | HYCOR BIOMEDICAL LLC |
| 45 | 00816879021905 | M014 | 74751 | 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. | Epicoccum purpurascens | HYCOR BIOMEDICAL LLC |
| 46 | 00816879021899 | M013 | 74749 | 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. | Phoma betae | HYCOR BIOMEDICAL LLC |
| 47 | 00816879021882 | M009 | 74746 | 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. | Fusarium moniliforme | HYCOR BIOMEDICAL LLC |
| 48 | 00816879021875 | M008 | 74745 | 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. | Helminthosporium halodes | HYCOR BIOMEDICAL LLC |
| 49 | 00816879021851 | W017 | 74477 | 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. | Kochia/Firebush Kochia scoparia | HYCOR BIOMEDICAL LLC |
| 50 | 00816879021820 | K082 | 74451 | 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. | Latex (U.S.) w/D.I. | HYCOR BIOMEDICAL LLC |