No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 07333066022307 | 34-2317-93 | 34-2317-93 | Phadia Maintenance Solution Small | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Phadia Maintenance Solution Small |
2 | 07333066019994 | 83-0008-01 | 83-0008-01 | EliA APS Positive Control 250 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | EliA APS Positive Control 250 |
3 | 07333066019987 | 83-0007-91 | 83-0007-91 | EliA APS Positive Control 100 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | EliA APS Positive Control 100 |
4 | 07333066019970 | 83-0006-71 | 83-0006-71 | EliA Celiac Positive Control 250 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | EliA Celiac Positive Control 250 |
5 | 07333066019963 | 34-2341-31 | 34-2341-31 | ImmunoCAP Specific IgE Control H | DHB | System, test, radioallergosorbent (rast) immunological | 2 | ImmunoCAP Specific IgE Control H |
6 | 07333066019949 | 34-2341-11 | 34-2341-11 | ImmunoCAP Specific IgE Control L | DHB | System, test, radioallergosorbent (rast) immunological | 2 | ImmunoCAP Specific IgE Control L |
7 | 07333066019857 | 34-2325-31 | 34-2325-31 | ImmunoCAP Autoimmunity Specific IgG Sample Diluent | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Autoimmunity Specific IgG Sample Diluent |
8 | 07333066019840 | 34-2316-11 | 34-2316-11 | ImmunoCAP Autoimmunity Specific IgG Sample Diluent | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Autoimmunity Specific IgG Sample Diluent |
9 | 07333066019826 | 34-2294-41 | 34-2294-41 | ImmunoCAP Specific IgG Conjugate | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Specific IgG Conjugate |
10 | 07333066019628 | 10-9414-01 | 10-9414-01 | Contains 2 vials of each IgG antibodies level (N: normal; L: low; H: high) for t Contains 2 vials of each IgG antibodies level (N: normal; L: low; H: high) for the ImmunoCAP Thyroid Peroxidase method. | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Thyroid Peroxidase IgG Antibodies Control NLH |
11 | 07333066014807 | DECC055390 | DECC055390 | EliA GliadinDP IgG Well | MST | Antibodies, gliadin | 2 | EliA GliadinDP IgG Well |
12 | 07333066017549 | 14-6016-01 | 14-6016-01 | ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee | PUW | System, test, radioallergosorbent (Rast) immunological, exempt allergens | 2 | ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee |
13 | 07333066017532 | 14-6015-01 | 14-6015-01 | ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee | PUW | System, test, radioallergosorbent (Rast) immunological, exempt allergens | 2 | ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee |
14 | 07333066014852 | DECC056490 | DECC056490 | EliA M2 Well | DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL | 2 | EliA M2 Well |
15 | 07333066014746 | DECC055310 | DECC055310 | EliA ß2-Glycoprotein I IgA Well | MSV | System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | EliA ß2-Glycoprotein I IgA Well |
16 | 07333066014692 | DECC055200 | DECC055200 | EliA Gliadin IgG Well | MST | Antibodies, gliadin | 2 | EliA Gliadin IgG Well |
17 | 07333066013138 | 83-0008-51 | 83-0008-51 | EliA IgM Conjugate 200 | DHR | SYSTEM, TEST, RHEUMATOID FACTOR | 2 | EliA IgM Conjugate 200 |
18 | 07333066013077 | 83-0007-21 | 83-0007-21 | EliA Celiac Positive Control 100 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | EliA Celiac Positive Control 100 |
19 | 07333066013060 | 83-0007-11 | 83-0007-11 | EliA CCP Positive Control 100 | NHX | ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) | 2 | EliA CCP Positive Control 100 |
20 | 07333066012841 | 83-0003-41 | 83-0003-41 | EliA IgA Curve Control Strip | MVM | Autoantibodies, endomysial(tissue transglutaminase) | 2 | EliA IgA Curve Control Strip |
21 | 07333066012780 | 83-0002-81 | 83-0002-81 | EliA IgA Conjugate | MVM | Autoantibodies, endomysial(tissue transglutaminase) | EliA IgA Conjugate | |
22 | 07333066011615 | 34-2273-31 | 34-2273-31 | ImmunoCAP Specific IgG Curve Control Strip | JJY | Multi-analyte controls, all kinds (assayed) | 1 | ImmunoCAP Specific IgG Curve Control Strip |
23 | 07333066010496 | 14-5341-01 | 14-5341-01 | ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut |
24 | 07333066009902 | 14-5304-10 | 14-5304-10 | ImmunoCAP Antigen RGm24, Stachybotrys atra | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Antigen RGm24, Stachybotrys atra |
25 | 07333066009841 | 14-5301-10 | 14-5301-10 | ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST |
26 | 07333066009193 | 14-5254-10 | 14-5254-10 | ImmunoCAP Allergen f335, Lupine seed | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen f335, Lupine seed |
27 | 07333066009094 | 14-5249-10 | 14-5249-10 | ImmunoCAP Rare Allergen Rf332, Mint | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rf332, Mint |
28 | 07333066008424 | 14-5209-10 | 14-5209-10 | ImmunoCAP Allergen Rf313, Anchovy | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf313, Anchovy |
29 | 07333066008363 | 14-5206-10 | 14-5206-10 | ImmunoCAP Allergen Rfx21, Fruits | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rfx21, Fruits |
30 | 07333066008288 | 14-5202-10 | 14-5202-10 | ImmunoCAP Allergen Rm208, Chaetomium globosum | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rm208, Chaetomium globosum |
31 | 07333066008059 | 14-5189-10 | 14-5189-10 | ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid |
32 | 07333066007953 | 14-5183-10 | 14-5183-10 | ImmunoCAP Allergen Rtx10, Tree pollen | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rtx10, Tree pollen |
33 | 07333066007496 | 14-5139-10 | 14-5139-10 | ImmunoCAP Rare Allergen Rf298, Tragacanth | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Rare Allergen Rf298, Tragacanth |
34 | 07333066006925 | 14-5086-10 | 14-5086-10 | ImmunoCAP Allergen Rf212, Mushroom (champignon) | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf212, Mushroom (champignon) |
35 | 07333066006642 | 14-5065-10 | 14-5065-10 | ImmunoCAP Allergen Rf221, Coffee | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf221, Coffee |
36 | 07333066006628 | 14-5064-10 | 14-5064-10 | ImmunoCAP Allergen Rf268, Clove | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf268, Clove |
37 | 07333066006574 | 14-5060-10 | 14-5060-10 | ImmunoCAP Allergen Rf291, Cauliflower | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf291, Cauliflower |
38 | 07333066006352 | 14-5044-10 | 14-5044-10 | ImmunoCAP Allergen Rf271, Anise | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rf271, Anise |
39 | 07333066006147 | 14-5026-10 | 14-5026-10 | ImmunoCAP Allergen wx209, Ambrosia sp. | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen wx209, Ambrosia sp. |
40 | 07333066005768 | 14-4990-01 | 14-4990-01 | ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy |
41 | 07333066005713 | 14-4983-01 | 14-4983-01 | ImmunoCAP Allergen w233, Allergen component nArt v 3 LTP, Mugwort | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen w233, Allergen component nArt v 3 LTP, Mugwort |
42 | 07333066005638 | 14-4972-01 | 14-4972-01 | ImmunoCAP Allergen g216, Allergen component nCyn d 1 Bermuda grass | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen g216, Allergen component nCyn d 1 Bermuda grass |
43 | 07333066005539 | 14-4963-01 | 14-4963-01 | ImmunoCAP Allergen f422, Allergen component rAra h 1 Peanut | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f422, Allergen component rAra h 1 Peanut |
44 | 07333066005508 | 14-4960-01 | 14-4960-01 | ImmunoCAP Allergen f419, Allergen component rPru p 1 PR-10, Peach | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f419, Allergen component rPru p 1 PR-10, Peach |
45 | 07333066005386 | 14-4950-10 | 14-4950-10 | ImmunoCAP Allergen Rw23, Yellow dock | MVU | Reagents, specific, analyte | 1 | ImmunoCAP Allergen Rw23, Yellow dock |
46 | 07333066004556 | 14-4843-01 | 14-4843-01 | ImmunoCAP Allergen f299, Sweet chestnut | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f299, Sweet chestnut |
47 | 07333066004488 | 14-4836-01 | 14-4836-01 | ImmunoCAP Allergen f203, Pistachio | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f203, Pistachio |
48 | 07333066004327 | 14-4820-01 | 14-4820-01 | ImmunoCAP Allergen f207, Clam | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f207, Clam |
49 | 07333066004303 | 14-4818-01 | 14-4818-01 | ImmunoCAP Allergen f284, Turkey meat | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f284, Turkey meat |
50 | 07333066003801 | 14-4434-01 | 14-4434-01 | ImmunoCAP Allergen f254, Plaice | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | ImmunoCAP Allergen f254, Plaice |
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 |