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 | 00813382010402 | 80109 | 80109 | KIT, OPTIGEN US Panel Control Reagent | OPTIGEN® US Panel Control Reagent | MINARIS MEDICAL AMERICA, INC. |
2 | 00813382010358 | 80108 | 80108 | UP20 Negative Control Reagent | UP20 Negative Control Reagent | MINARIS MEDICAL AMERICA, INC. |
3 | 00813382010280 | 80107 | 80107 | UP20 Positive Control Reagent | UP20 Positive Control Reagent | MINARIS MEDICAL AMERICA, INC. |
4 | 00813382010099 | 82062 | 82062 | OPTIGEN Negative Control | OPTIGEN® Negative Control Reagent | MINARIS MEDICAL AMERICA, INC. |
5 | 00813382010082 | 82061 | 82061 | OPTIGEN Positive Control | OPTIGEN® Positive Control Reagent | MINARIS MEDICAL AMERICA, INC. |
6 | 00811727013330 | P1035-96 | P1035-96 | IgE for the quantitative determination of Immunoglobulin E (IgE) concentration i IgE for the quantitative determination of Immunoglobulin E (IgE) concentration in human serum. For in vitro diagnostic use only. 96 Tests. | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
7 | 00630414962351 | 10385232 | L2SUBM | Substrate Module - IMMULITE - CONS - 2x1000 Tests | IMMULITE® 2000 Systems SUBS | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
8 | 00630414599397 | 10995616 | 10995616 | IgE Multi-Diluent Atellica IM - CONS (2PK) 2 x 5mL | Atellica IM tIgE DIL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
9 | 00630414599380 | 10995615 | 10995615 | IgE (tIgE) Atellica IM - RGT 50T | Atellica IM tIgE | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
10 | 00630414599373 | 10995614 | 10995614 | IgE (tIgE) Atellica IM – RGT 250T | Atellica IM tIgE | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
11 | 00630414177489 | 10309986 | 110778 | IgE - CENTAUR - RGT - 250 tests | ADVIA Centaur® tIgE | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
12 | 00630414177472 | 10309985 | 110777 | IgE - CENTAUR - RGT - 50 tests | ADVIA Centaur® tIgE | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
13 | 00630414175331 | 10309952 | 110324 | IgE Dil.RP (2PK) - CENTAUR - CAL - 2x5mL | ADVIA Centaur® IgE DIL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
14 | 00380740156404 | 06K5622 | 06K5622 | Quantia Ferritin/Myoglobin/IgE Control | ARCHITECT | ABBOTT LABORATORIES |
15 | 00380740156367 | 06K5004 | 06K5004 | Quantia IgE Calibrators | ARCHITECT | ABBOTT LABORATORIES |
16 | 00380740156282 | 06K4241 | 06K4241 | Quantia Immunoglobulin E | ARCHITECT | ABBOTT LABORATORIES |
17 | 00380740054243 | 6K42-40 | 06K4240 | Quantia Immunoglobulin E | ARCHITECT | ABBOTT LABORATORIES |
18 | 00380740044848 | 6K56-21 | 06K5621 | Quantia Ferritin/Myoglobin/IgE Control | ARCHITECT | ABBOTT LABORATORIES |
19 | 00380740030100 | 6K50-02 | 06K5002 | Quantia IgE Calibrators | ARCHITECT | ABBOTT LABORATORIES |
20 | B24225IGEHUE010 | 25-IGEHU-E01 | 25-IGEHU-E01 | The Total IgE ELISA is intended for use in the quantitative determination of imm The Total IgE ELISA is intended for use in the quantitative determination of immunoglobulin E in human serum. The assay is to be used for the assessment of hypersensitive and allergic reactions in patients. | Total IgE ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
21 | B1761040 | 1 | 104002 | Goat antiserum to Human IgE | Antiserum to Human IgE (epsilon specific) | KENT LABORATORIES INC |
22 | 15099590701727 | C22529 | Total Immunoglobulin E (IgE) Reagent kit for AU/DxC AU clinical chemistry analyzers. | Total Immunoglobulin E (IgE) | BECKMAN COULTER, INC. | |
23 | 15099590227029 | 474620 | 474620 | IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent | IMMAGE | BECKMAN COULTER, INC. |
24 | 15099590221324 | 35000 | 35000 | The Access Total IgE assay is a paramagnetic particle, chemiluminescent immunoas The Access Total IgE assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative determination of total E (IgE) levels in human serum and plasma (heparin, EDTA) using the Access Immunoassay Systems. | Access Total IgE | BECKMAN COULTER, INC. |
25 | 15099590221317 | 35005 | 35005 | The Access Total IgE Calibrators are intended to calibrate the Access Total IgE The Access Total IgE Calibrators are intended to calibrate the Access Total IgE assay for the quantitative determination of total IgE levels in human serum and plasma (heparin, EDTA) using the Access Immunoassay Systems. | Access Total IgE Calibrators | BECKMAN COULTER, INC. |
26 | 15099590221300 | 35006 | 35006 | The Access Total IgE Calibrator S0 is intended for use with the Access Total IgE The Access Total IgE Calibrator S0 is intended for use with the Access Total IgE assay to dilute patient samples containing analyte concentrations greater than the analyte specific S6 calibrator. | Access Total IgE Calibrator S0 | BECKMAN COULTER, INC. |
27 | 14560189210155 | N/A | ST AIA-PACK IgEII | TOSOH CORPORATION | ||
28 | 07333066019864 | 34-2325-42 | 34-2325-42 | ImmunoCAP Total IgE Conjugate 400 | ImmunoCAP Total IgE Conjugate 400 | PHADIA AB |
29 | 07333066019796 | 34-2274-81 | 34-2274-81 | ImmunoCAP Total IgE Calibrator Strip | ImmunoCAP Total IgE Calibrator Strip | PHADIA AB |
30 | 07333066019789 | 34-2274-51 | 34-2274-51 | ImmunoCAP Total IgE Curve Control Strip | ImmunoCAP Total IgE Curve Control Strip | PHADIA AB |
31 | 07333066019772 | 34-2272-22 | 34-2272-22 | ImmunoCAP Total IgE Conjugate 100 | ImmunoCAP Total IgE Conjugate 100 | PHADIA AB |
32 | 07333066019673 | 10-9517-02 | 10-9517-02 | Contains one bottle of Total IgE Conjugate and four vials of each Total IgE Curv Contains one bottle of Total IgE Conjugate and four vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method. | ImmunoCAP Total IgE | PHADIA AB |
33 | 07333066019642 | 10-9447-01 | 10-9447-01 | Contains two vials of each Total IgE Control (L, M, H) for the ImmunoCAP Total IgE method. | ImmunoCAP Total IgE Control LMH | PHADIA AB |
34 | 07333066019529 | 10-9257-01 | 10-9257-01 | Contains three vials of each Total IgE Curve Control (CC-1, CC-2) for the Immuno Contains three vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method. | ImmunoCAP Total IgE Curve Controls | PHADIA AB |
35 | 07333066019512 | 10-9252-01 | 10-9252-01 | Contains one vial of each Total IgE Calibrator (Cal-2, Cal-10, Cal-50, Cal-200, Contains one vial of each Total IgE Calibrator (Cal-2, Cal-10, Cal-50, Cal-200, Cal-1000, Cal-5000) to form a complete calibration curve for the ImmunoCAP Total IgE method. | ImmunoCAP Total IgE Calibrators | PHADIA AB |
36 | 07333066011660 | 34-2275-01 | 34-2275-01 | ImmunoCAP IgE/ECP/Tryptase Sample Diluent | ImmunoCAP IgE/ECP/Tryptase Sample Diluent | PHADIA AB |
37 | 07333066011356 | 34-2264-51 | 34-2264-51 | ImmunoCAP IgE/ECP/Tryptase Sample Diluent | ImmunoCAP IgE/ECP/Tryptase Sample Diluent | PHADIA AB |
38 | 07333066004037 | 14-4509-01 | 14-4509-01 | ImmunoCAP Total IgE Anti-IgE | ImmunoCAP Total IgE Anti-IgE | PHADIA AB |
39 | 05055273203929 | IE7308 | IE7308 | An IgE test system is a device intended for the quantitative in vitro determinat An IgE test system is a device intended for the quantitative in vitro determination of immunoglobulin E (IgE) concentration in human serum or plasma | IgE | RANDOX LABORATORIES LIMITED |
40 | 05055273203912 | IE2492 | IE2492 | This product is intended for in vitro diagnostic use in the quality control of I This product is intended for in vitro diagnostic use in the quality control of IgE on clinical chemistry systems. | IgE CAL SET | RANDOX LABORATORIES LIMITED |
41 | 05051700010122 | PX014 | Sheep Anti-Human IgE Immunofixation Grade | THE BINDING SITE GROUP LIMITED | ||
42 | 04560189211087 | N/A | AIA-PACK IgEII Sample Diluting Solution | TOSOH CORPORATION | ||
43 | 04560189211070 | N/A | AIA-PACK IgEII Calibrator Set | TOSOH CORPORATION | ||
44 | 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. |
45 | 00842768008078 | 10446129 | OQTG15 | Quantitative determination of IgE in human serum and plasma on BN Systems | N Latex IgE mono | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
46 | 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 |
47 | 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 |
48 | 00816879022285 | 74120 | Hytec Specific/Total IgE Control | HYCOR BIOMEDICAL LLC | ||
49 | 00816879022063 | 71207 | SPECIFIC IGE CONTROL KIT | HYCOR BIOMEDICAL LLC | ||
50 | 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 |