| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00813382012178 | 85168 | 85168 | KIT, OPTIGEN US Environmental 36 (40ND) | PUW | System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | 2 | OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (40ND) |
| 2 | 00813382010426 | 85081 | 85081 | KIT, OPTIGEN US Inhalant 36 (100 ND) | PUW | System, test, radioallergosorbent (Rast) immunological, exempt allergens | 2 | OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36(100 ND) |
| 3 | 00813382010389 | 85064 | 85064 | KIT, OPTIGEN US Food 20 | PUW,DHB | System, test, radioallergosorbent (Rast) immunological, exempt allergens,System, System, test, radioallergosorbent (Rast) immunological, exempt allergens,System, test, radioallergosorbent (rast) immunological | 2 | OPTIGEN® Allergen-Specific IgE Assay - US Food 20 Panel |
| 4 | 00813382010358 | 80108 | 80108 | UP20 Negative Control Reagent | DGC | IGE, ANTIGEN, ANTISERUM, CONTROL | UP20 Negative Control Reagent | |
| 5 | 00813382010136 | 84506 | 84506 | KIT, Pediatric Comprehensive | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | CLA® Allergen-Specific IgE Assay - Pediatric Comprehensive Panel |
| 6 | 00813382010099 | 82062 | 82062 | OPTIGEN Negative Control | DGC | IGE, ANTIGEN, ANTISERUM, CONTROL | OPTIGEN® Negative Control Reagent | |
| 7 | 00813382012185 | 85268 | 85268 | KIT, OPTIGEN US Environmental 36 (100ND) | PUW | System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | 2 | OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (100ND) |
| 8 | 00813382010150 | 84509 | 84509 | KIT, Southwestern Inhalant | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | CLA® Allergen-Specific IgE Assay - Southwestern Inhalant Panel |
| 9 | 00813382010143 | 84507 | 84507 | KIT, Southeastern Inhalant | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | CLA® Allergen-Specific IgE Assay - Southeastern Inhalant Panel |
| 10 | 00813382010112 | 84504 | 84504 | KIT, Northeastern Inhalant | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | CLA® Allergen-Specific IgE Assay - Northeastern Inhalant Panel |
| 11 | 00813382010037 | 85068 | 85068 | KIT, OPTIGEN® Environmental 36 (20T) | PUW | System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | 2 | OPTIGEN® Allergen-Specific IgE Assay - Environmental 36 (20T) |
| 12 | 00813382010204 | 95413 | 95413 | Automated In Vitro Allergy Diagnostic System | DHB | System, test, radioallergosorbent (rast) immunological | 2 | OPTIGEN® AP 3600™ Automated Instrument |
| 13 | 00813382010181 | 94173 | 94173 | CLA Neg Ctrl Serum | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | CLA® Negative Control Serum | |
| 14 | 00813382010334 | 84508 | 84508 | Kit, Southern | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | CLA® Allergen-Specific IgE Assay - Eastern |
| 15 | 00813382010105 | 84502 | 84502 | KIT, Eastern | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | CLA® Allergen-Specific IgE Assay - Eastern |
| 16 | 00813382010075 | 85003 | 85003 | KIT, OPTIGEN Universal Panel 20 | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel |
| 17 | 00813382010006 | 85003 | 85003 | KIT, OPTIGEN Universal Panel 20 | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel |
| 18 | 00813382012154 | 85167 | 85167 | KIT, OPTIGEN US Food 30 (40ND) | PUW | System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | 2 | OPTIGEN® Allergen-Specific IgE Assay - US Food 30 (40ND) |
| 19 | 00813382010167 | 84511 | 84511 | KIT, Western Inhalant | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | CLA® Allergen-Specific IgE Assay - Western Inhalant Panel |
| 20 | 00813382010020 | 85267 | 85267 | KIT, OPTIGEN US Food 30 (100ND) | PUW | System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | 2 | OPTIGEN® Allergen-Specific IgE Assay - US Food 30 (100ND) |
| 21 | 00813382010440 | 85066 | 85066 | KIT, OPTIGEN US Food 25 | PUW | System, test, radioallergosorbent (Rast) immunological, exempt allergens | 2 | OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND) |
| 22 | 00813382010433 | 85082 | 85082 | KIT, OPTIGEN US Food 25 (100 ND) | PUW | System, test, radioallergosorbent (Rast) immunological, exempt allergens | 2 | OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND) |
| 23 | 00813382010396 | 85065 | 85065 | KIT, OPTIGEN US Mix 36 | DHB,PUW | System, test, radioallergosorbent (rast) immunological,System, test, radioallerg System, test, radioallergosorbent (rast) immunological,System, test, radioallergosorbent (Rast) immunological, exempt allergens | 2 | OPTIGEN® Allergen-Specific IgE Assay - US Mix 36 Panel |
| 24 | 00813382010372 | 85063 | 85063 | KIT, OPTIGEN US Inhalant 36 | PUW,DHB | System, test, radioallergosorbent (Rast) immunological, exempt allergens,System, System, test, radioallergosorbent (Rast) immunological, exempt allergens,System, test, radioallergosorbent (rast) immunological | 2 | OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36 Panel |
| 25 | 00813382010174 | 84518 | 84518 | KIT, Moderate Food | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | CLA® Allergen-Specific IgE Assay - Moderate Food Panel |
| 26 | 00813382010129 | 84505 | 84505 | KIT, Northwestern Inhalant | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | CLA® Allergen-Specific IgE Assay - Northwestern Inhalant Panel |
| 27 | 00813382010044 | 95019 | 95019 | CLA-1 Luminometer | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | CLA-1™ Luminometer |
| 28 | 00813382010013 | 85067 | 85067 | KIT, OPTIGEN® Food 29 (20T) | PUW | System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | 2 | OPTIGEN® Allergen-Specific IgE Assay - Food 29 (20T) |
| 29 | 00813382010280 | 80107 | 80107 | UP20 Positive Control Reagent | DGC | IGE, ANTIGEN, ANTISERUM, CONTROL | UP20 Positive Control Reagent | |
| 30 | 00813382010211 | 93602 | 93602 | AP 720S™ Semi-Automated Processor | DHB | System, test, radioallergosorbent (rast) immunological | 2 | AP 720S™ Semi-Automated Processor |
| 31 | 00813382010198 | 93026 | 93026 | CLA Pos Ctrl Serum | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | CLA® Positive Control Serum | |
| 32 | 00813382010082 | 82061 | 82061 | OPTIGEN Positive Control | DGC | IGE, ANTIGEN, ANTISERUM, CONTROL | OPTIGEN® Positive Control Reagent |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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 |
| 2 | 00816879022285 | 74120 | Hytec Specific/Total IgE Control | HYCOR BIOMEDICAL LLC | ||
| 3 | 00816879022063 | 71207 | SPECIFIC IGE CONTROL KIT | HYCOR BIOMEDICAL LLC | ||
| 4 | 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 |
| 5 | 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 |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |
| 16 | 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 |
| 17 | 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 |
| 18 | 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 |
| 19 | 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 |
| 20 | 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 |
| 21 | 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 |
| 22 | 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 |
| 23 | 00816879021523 | G014 | 74340 | Avena sativa | Oat Pollen, Cultivated Avena sativa | HYCOR BIOMEDICAL LLC |
| 24 | 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 |
| 25 | 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 |
| 26 | 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 |
| 27 | 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 |
| 28 | 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 |
| 29 | 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 |
| 30 | 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 |
| 31 | 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 |
| 32 | 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 |
| 33 | 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 |
| 34 | 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 |
| 35 | 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 |
| 36 | 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 |
| 37 | 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 |
| 38 | 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 |
| 39 | 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 |
| 40 | 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 |
| 41 | 00816879021219 | F008 | 74239 | Corn | Corn | HYCOR BIOMEDICAL LLC |
| 42 | 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 |
| 43 | 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 |
| 44 | 00816870021959 | 2575-300 | 2575-300E | Monobind AccuLite IgE CLIA Kit - 960 Wells | MONOBIND, INC. | |
| 45 | 00816870021942 | 2575-300 | 2575-300D | Monobind AccuLite IgE CLIA Kit - 480 Wells | MONOBIND, INC. | |
| 46 | 00816870021935 | 2575-300 | 2575-300B | Monobind AccuLite IgE CLIA Kit - 192 Wells | MONOBIND, INC. | |
| 47 | 00816870021928 | 2575-300 | 2575-300A | Monobind AccuLite IgE CLIA Kit - 96 Wells | MONOBIND, INC. | |
| 48 | 00816870020273 | 2525-300 | 2525-300E | Monobind AccuBind IgE ELISA Kit - 960 Wells | MONOBIND, INC. | |
| 49 | 00816870020266 | 2525-300 | 2525-300D | Monobind AccuBind IgE ELISA Kit - 480 Wells | MONOBIND, INC. | |
| 50 | 00816870020259 | 2525-300 | 2525-300B | Monobind AccuBind IgE ELISA Kit - 192 Wells | MONOBIND, INC. |