HYCOR BIOMEDICAL

Noveos Immunoassay Analyzer NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass - G006, Phleum pratense NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus NOVEOS Capture Reagent F013, Peanut (Arachis hypogaea) NOVEOS Capture Reagent F076, Bos d 4 a-lactalbumin, Milk NOVEOS Capture Reagent F232, Gal d 2 Ovalbumin, Egg NOVEOS Capture Reagent F077, Bos d 5 b-lactoglobulin, Milk Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae NOVEOS Specific IgE, Capture Reagent F041, Salmon (Salmo salar) NOVEOS Specific IgE, Capture Reagent F290, Oyster (Ostrea edulis) NOVEOS Specific IgE, Capture Reagent F036, Coconut (Cocos nucifera) NOVEOS Specific IgE, Capture Reagent F075, Egg Yolk (Gallus gallus) NOVEOS Specific IgE, Capture Reagent F040, Tuna (Thunnus sp.) NOVEOS Specific IgE, Capture Reagent F203, Pistachio Nut (Pistacia vera) NOVEOS Specific IgE, Capture Reagent F018, Brazil Nut (Bertholletia excelsa) NOVEOS Specific IgE, Capture Reagent F201, Pecan Nut (Carya illinoensis) NOVEOS Capture Reagent F207, Clam (Mercenaria mercenaria) NOVEOS Capture Reagent F024, Shrimp (Shrimp spp.) NOVEOS Capture Reagent F256, Walnut (Juglans spp.) NOVEOS Capture Reagent I006, German Cockroach (Blatella germanica) Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria NOVEOS Specific IgE, Capture Reagent G008 Meadow Grass, Kentucky Blue NOVEOS Specific IgE, Capture Reagent W010 Goosefoot NOVEOS Specific IgE, Capture Reagent G005 Rye Grass NOVEOS Specific IgE, Capture Reagent W019 Wall Pellitory NOVEOS Specific IgE, Capture Reagent T002 Gray Alder NOVEOS Specific IgE, Capture Reagent M003 Aspergillus fumigatus NOVEOS Specific IgE, Capture Reagent T014 Cottonwood Tree NOVEOS Specific IgE, Capture Reagent T218 Virginia Live Oak – Quercus virginiana NOVEOS Specific IgE, Capture Reagent H001 House Dust - Greer NOVEOS Specific IgE, Capture Reagent W011 Russian Thistle NOVEOS Specific IgE, Capture Reagent T022 Pecan, Hickory NOVEOS Specific IgE, Capture Reagent T010 Walnut NOVEOS Specific IgE, Capture Reagent G009 Redtop, Bentgrass NOVEOS Specific IgE, Capture Reagent G017 Bahia Grass NOVEOS Specific IgE, Capture Reagent T070 Mulberry NOVEOS Specific IgE, Capture Reagent T015 White Ash NOVEOS Specific IgE, Capture Reagent G001 Sweet Vernal Grass NOVEOS Specific IgE, Capture Reagent W009 English Plantain NOVEOS Specific IgE, Capture Reagent F031 Carrot NOVEOS Specific IgE, Capture Reagent G004 Meadow Fescue NOVEOS Specific IgE, Capture Reagent W006 Mugwort NOVEOS Specific IgE, Capture Reagent T001 Maple Box Elder NOVEOS Specific IgE, Capture Reagent M002 Cladosporium herbarum NOVEOS Specific IgE, Capture Reagent T006 Mountain Juniper NOVEOS Specific IgE, Capture Reagent T009 Olive Tree NOVEOS Specific IgE, Capture Reagent T008 Elm NOVEOS Specific IgE, Capture Reagent T011 Maple Leaf Sycamore, London Plane NOVEOS Specific IgE, Capture Reagent W018 Sheep Sorrel NOVEOS Specific IgE, Capture Reagent G003 Cocksfoot NOVEOS Specific IgE, Capture Reagent W014 Common Pigweed NOVEOS Probe Wash Pack NOVEOS Immunoassay Analyzer NOVEOS IgE Calibrator Set (six levels: 07, 0.35, 0.70, 3.5, 17.5, 100 kU/L) NOVEOS IgE Positive Control Pack NOVEOS Specific IgE (sIgE), Capture Reagent Common Silver Birch - T003, Betula verrucosa NOVEOS Specific IgE (sIgE), Capture Reagent Common Ragweed - W001, Ambrosia artemisiifolia NOVEOS IgE Negative Control Pack NOVEOS IgE Calibrator Antibody Pack NOVEOS Wash Buffer Concentrate Pack NOVEOS Specific IgE (sIgE), Capture Reagent Egg White - F001, Gallus gallus NOVEOS Specific IgE (sIgE), Capture Reagent Cow's Milk - F002, Bos taurus NOVEOS Specific IgE (sIgE), Capture Reagent Johnson Grass - G010, Sorghum halepense NOVEOS Specific IgE (sIgE), Capture Reagent Oak - T007, Quercus alba NOVEOS Cuvette Wash Pack NOVEOS Specific IgE (sIgE), Capture Reagent Dog Dander - E005, Canis familiaris NOVEOS Diluent A NOVEOS Conjugate IgE NOVEOS Fluo Beads NOVEOS Substrate A NOVEOS Specific IgE (sIgE), Capture Reagent Bermuda Grass - G002, Cynodon dactylon NOVEOS Substrate B

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only