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 | 00813382010402 | 80109 | 80109 | KIT, OPTIGEN US Panel Control Reagent | DGC | IGE, ANTIGEN, ANTISERUM, CONTROL | 2 | OPTIGEN® US Panel Control Reagent |
15 | 00813382010334 | 84508 | 84508 | Kit, Southern | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | CLA® Allergen-Specific IgE Assay - Eastern |
16 | 00813382010105 | 84502 | 84502 | KIT, Eastern | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | CLA® Allergen-Specific IgE Assay - Eastern |
17 | 00813382010075 | 85003 | 85003 | KIT, OPTIGEN Universal Panel 20 | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel |
18 | 00813382010006 | 85003 | 85003 | KIT, OPTIGEN Universal Panel 20 | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel |
19 | 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) |
20 | 00813382010167 | 84511 | 84511 | KIT, Western Inhalant | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | CLA® Allergen-Specific IgE Assay - Western Inhalant Panel |
21 | 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) |
22 | 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) |
23 | 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) |
24 | 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 |
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 | 00816879025255 | G008 | 8632850 | NOVEOS Capture Reagent Pack Kentucky Blue Grass, Poa pratensis | HYCOR BIOMEDICAL LLC | |
2 | 00816879024241 | T022 | 8633190 | NOVEOS Pecan, Hickory, Carya illinoinensis Capture Reagent Pack | HYCOR BIOMEDICAL LLC | |
3 | 00816879023947 | G004 | 8632810 | NOVEOS Capture Reagent Pack Meadow Fescue, Festuca elatior | HYCOR BIOMEDICAL LLC | |
4 | 00816879023596 | G006 | 63283 | NOVEOS Timothy Grass, Phleum pratense | HYCOR BIOMEDICAL LLC | |
5 | 00816879023527 | E001 | 63212 | NOVEOS Cat Dander, Felis domesticus | HYCOR BIOMEDICAL LLC | |
6 | 00816879023510 | D002 | 63208 | NOVEOS House Dust Mite, Dermatophagoides farinae | HYCOR BIOMEDICAL LLC | |
7 | 00816879023503 | D001 | 63207 | NOVEOS House Dust Mite, Dermatophagoides pteronyssinus | HYCOR BIOMEDICAL LLC | |
8 | 00816879023169 | 63190 | NOVEOS Cuvette Wash Pack | HYCOR BIOMEDICAL LLC | ||
9 | 00816879023114 | 117450-001 | NOVEOS Cuvette Arc Pack | HYCOR BIOMEDICAL LLC | ||
10 | 00816879023107 | 119844-001 | NOVEOS Optics Tip Pack | HYCOR BIOMEDICAL LLC | ||
11 | 00816879023091 | 118877-001 | NOVEOS Substrate Mix Container Pack | HYCOR BIOMEDICAL LLC | ||
12 | 00816879023077 | 63180 | NOVEOS IgE Calibrator Antibody Pack | HYCOR BIOMEDICAL LLC | ||
13 | 00816879023053 | 63170 | NOVEOS Probe Wash Pack | HYCOR BIOMEDICAL LLC | ||
14 | 00816879023046 | 63165 | NOVEOS Wash Buffer Concentrate Pack | HYCOR BIOMEDICAL LLC | ||
15 | 00816879023039 | 63155 | NOVEOS IgE Negative Control Pack | HYCOR BIOMEDICAL LLC | ||
16 | 00816879023022 | 63150 | NOVEOS IgE Positive Control Pack | HYCOR BIOMEDICAL LLC | ||
17 | 00816879023015 | 63145 | NOVEOS IgE Calibrator Set | HYCOR BIOMEDICAL LLC | ||
18 | 00816879023008 | 63140 | NOVEOS IgE Common Kit | HYCOR BIOMEDICAL LLC | ||
19 | 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 |
20 | 00816879022865 | Maple/Box Elder | 74407 | Hytec | HYCOR BIOMEDICAL LLC | |
21 | 00816879022858 | MCS Specific Total IgE Conjugate | 308174 | HYTEC | HYCOR BIOMEDICAL LLC | |
22 | 00816879022841 | Specific IgE Reference Disc | 74112 | HYTEC | HYCOR BIOMEDICAL LLC | |
23 | 00816879022322 | 288-6002-350 | Hytec Automated EIA System for Total IgE and Specific IgE | HYCOR BIOMEDICAL LLC | ||
24 | 00816879022315 | 288197 | 288197 | Hytec Probe Cleaning Solution | HYCOR BIOMEDICAL LLC | |
25 | 00816879022308 | 74155 | Hytec EIA Kit | HYCOR BIOMEDICAL LLC | ||
26 | 00816879022292 | 74118 | IgE Reference Disc | HYCOR BIOMEDICAL LLC | ||
27 | 00816879022261 | 308053 | 74130 | Four vials per package. | PnPP Tablets | HYCOR BIOMEDICAL LLC |
28 | 00816879022247 | 308050 | Substrate Diluent | HYCOR BIOMEDICAL LLC | ||
29 | 00816879022223 | 309046 | Total IgE Sample Diluent | HYCOR BIOMEDICAL LLC | ||
30 | 00816879022216 | 308174 | 308174 | MCS Specific/Total IgE Conjugate | HYCOR BIOMEDICAL LLC | |
31 | 00816879022186 | 312500 | Tubes (9x45mm plastic) | HYCOR BIOMEDICAL LLC | ||
32 | 00816879022148 | 308126 | EIA Wash Solution | HYCOR BIOMEDICAL LLC | ||
33 | 00816879022131 | 308151 | 308151 | Stop Solution (Allergy) | HYCOR BIOMEDICAL LLC | |
34 | 00816879022100 | 74154 | 74154 | Hytec Specific/Total IgE EIA | HYCOR BIOMEDICAL LLC | |
35 | 00816879022094 | 74129 | 74129 | IgE Extended Calibrator Set | HYCOR BIOMEDICAL LLC | |
36 | 00816879022087 | 74119 | Specific IgE calibrator set | HYCOR BIOMEDICAL LLC | ||
37 | 00816879022070 | 74112 | 74112 | IgE Reference Discs | HYCOR BIOMEDICAL LLC | |
38 | 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 |
39 | 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 |
40 | 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 |
41 | 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 |
42 | 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 |
43 | 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 |
44 | 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 |
45 | 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 |
46 | 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 |
47 | 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 |
48 | 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 |
49 | 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 |
50 | 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 |