{"data":{"id":"us/21-cfr-866.5750","jurisdiction":"us","citation":"21 CFR 866.5750","heading":"Radioallergosorbent (RAST) immunological test system.","body":"(a) Identification. A radioallergosorbent immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.\n(b) Classification. Class II (special controls). The device, when intended to detect any of the allergens included in Table 1 in this paragraph, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.\nTable 1—Class II Exempt Allergens Under § 866.5750—Radioallergosorbent (RAST) Immunological Test Systems\nAllergen code Allergen product Source (taxonomical name)\nGrass Pollens\ng1 Sweet vernal grass Anthoxanthum odoratum.\ng3 Cocksfoot grass, Orchard grass Dactylis glomerata.\ng4 Meadow fescue Festuca elatior.\ng5 Rye-grass (perennial rye grass) Lolium perenne.\ng7 Common reed (common reed grass) Phragmites communis.\ng8 Meadow grass, Kentucky blue (June grass) Poa pratensis.\ng9 Redtop, Bentgrass Agrostis stolonifera, Agrostis gigantea (Agrostis alba).\ng11 Brome grass Bromus inermis.\ng12 Cultivated rye (cultivated rye grass) Secale cereale.\ng13 Velvet grass Holcus lanatus.\ng14 Cultivated oat (cultivated oat grass) Avena sativa.\ng15 Cultivated wheat (cultivated wheat grass) Triticum aestivum (Triticum spp.).\ng16 Meadow foxtail (meadow foxtail grass) Alopecurus pratensis.\ng17 Bahia grass Paspalum notatum.\ng24 Wheat grass, Western Agropyron smithii (Elymus smithii).\ng30 Bluegrass, annual Poa annua.\ng70 Wild rye grass Elymus triticoides Elymus condensatus.\ng71 Canary grass Phalaris arundinacea.\ng201 Barley, cultivated Hordeum vulgare.\ng202 Maize, corn (cultivated corn) Zea mays.\ng203 Salt grass Distichlis spicata.\ng204 False oat-grass Arrhenatherum elatius.\ng216 Cyn d 1 Cynodon dactylon.\ng701 Phl p 1.0102, Phl p 5.0101 Phleum pratense.\ng702 Phl p 7.0101 Phleum pratense.\ng703 Phl p 12.0101 Phleum pratense.\nWeed Pollens\nw2 Western ragweed Ambrosia psilostachya.\nw4 False ragweed Ambrosia acanthicarpa (Franseria acanthicarpa).\nw5 Wormwood Artemisia absinthium Artemisia annua.\nw6 Mugwort Artemisia vulgaris.\nw7 Marguerite, ox-eye daisy Chrysanthemum leucanthemum.\nw8 Dandelion Taraxacum vulgare, Taraxacum officinale.\nw9 Plantain (English), Ribwort Plantago lanceolata.\nw10 Goosefoot, lamb's quarters Chenopodium album.\nw11 Saltwort (prickly), Russian thistle Salsola kali (Salsola pestifer).\nw12 Goldenrod Solidago virgaurea (Solidago spp.).\nw13 Cocklebur, common Xanthium commune.\nw14 Common pigweed (rough pigweed) Amaranthus retroflexus.\nw15 Scale, Lenscale Atriplex lentiformis.\nw16 Rough marsh elder Iva ciliate, Iva annua.\nw17 Firebush (Kochia) Kochia scoparia.\nw18 Sheep sorrel Rumex acetosella.\nw19 Wall pellitory Parietaria officinalis.\nw20 Nettle (Common stinging nettle) Urtica dioica.\nw21 Wall pellitory Parietaria judaica.\nw22 Japanese hop (careless weed) Humulus japonicas (Humulus scandens).\nw23 Yellow dock, Yellow dockweed Rumex crispus.\nw24 Spiny pigweed Amaranthus spinosus.\nw27 Carnation Dianthus spp.\nw28 Rose Rosa rugosa.\nw33 Clover Trifolium pratense.\nw35 Mexican tea Chenopodium ambrosioides.\nw36 Rabbit bush Ambrosia deltoidea (Franseria deltoides).\nw37 Salt bush, annual Atriplex wrightii.\nw39 Water hemp, Western Amaranthus rudis (Acnida tamariscina).\nw41 Burrobrush Hymenoclea salsola.\nw42 Poverty weed Baccharis neglecta.\nw43 Common sagebrush Artemisia tridentata.\nw45 Alfalfa Medicago sativa.\nw46 Dog fennel Eupatorium capillifolium.\nw53 Geranium Geranium spp.\nw67 Groundsel bush Baccharis halimifolia.\nw69 Iodine bush Allenrolfea occidentalis.\nw70 Ragweed, slender Ambrosia confertiflora.\nw75 Wing scale (wingscale) Atriplex canescens.\nw82 Careless weed Amaranthus palmeri, Amaranthus hybridus.\nw90 Japanese hop Humulus japonicas (Humulus scandens).\nw203 Rape (rape pollen) Brassica napus.\nw204 Sunflower Helianthus annuus.\nw206 Camomile Matricaria chamomilla.\nw207 Lupin Lupinus spp.\nw210 Sugar-beet Beta vulgaris.\nw211 Par j 2.0101 Parietaria judaica.\nw231 Art v 1 Artemisia vulgaris (Mugwort).\nw232 Sal k 1 Salsola kali.\nw233 Art v 3 Artemisa vulgaris (LTP, Mugwort).\nw234 Pla l 1 Plantago lanceolata.\nw235 Che a 1.0101 Chenopodium album.\nw236 Mer a 1.0101 Mercurialis annua.\na753 Art v 1 Artemisia vulgaris (Mugwort weed).\nTree Pollens\nt1 Box-elder (Maple) Acer negundo, Acer saccharum.\nt2 Gray alder, speckled alder (alder) Alnus incana.\nt4 Hazel, hazelnut Corylus avellana, Corylus americana.\nt5 American beech (beech) Fagus grandifolia (Fagus americana).\nt6 Mountain juniper, Mountain cedar Juniperus ashei (Juniperus sabinoides).\nt8 Elm Ulmus americana.\nt9 Olive Olea europaea.\nt10 Walnut Juglans californica, Juglans nigra.\nt11 Maple leaf sycamore, London plane, Plane tree Platanus acerifolia.\nt61 Sycamore Platanus occidentalis.\nt12 Willow Salix caprea, Salix nigra.\nt14 Cottonwood (Eastern Cottonwood/Black Cottonwood) Populus deltoides.\nt15 White ash Fraxinus americana.\nt16 White pine Pinus strobus.\nt18 Eucalyptus, gum-tree Eucalyptus globulus (Eucalyptus spp.).\nt19/t26 Acacia Acacia longifolia (Acacia spp.).\nt20 Mesquite Prosopis glandulosa/Prosopis juliflora.\nt21 Melaleuca, cajeput tree Melaleuca quinquenervia (Melaleuca leucadendron).\nt22 Pecan, hickory Carya illinoinensis (Carya pecan).\nt23 Italian/Mediterranean/funeral cypress Cupressus sempervirens.\nt24 Japanese cypress Chamaecyparis obtusa (Chamaecyparis spp.).\nt25 Ash Fraxinus excelsior.\nt27 Maple, red Acer rubrum.\nt29 Acacia Acacia spp.\nt30 Birch, white Betula populifolia.\nt32 Willow, black Salix nigra.\nt33 Ash, Arizona Fraxinus velutina.\nt35 Cedar, salt Tamarix gallica.\nt37 Bald cypress (white bald cypress) Taxodium distichum.\nt38 Elm, Chinese/Siberian Ulmus pumila.\nt40 Hazelnut tree Corylus americana.\nt41 White hickory Carya alba (Carya tomentosa).\nt42 Oak, red Quercus rubra.\nt43 Loblolly pine Pinus taeda.\nt44 Hackberry Celtis occidentalis.\nt45 Cedar elm Ulmus crassifolia.\nt47 Juniper, one seed Juniperus monosperma.\nt48 Pine, lodgepole Pinus contorta.\nt49 Pine, ponderosa Pinus ponderosa.\nt50 Beech, European Fagus sylvatica.\nt51 Tree of Heaven Ailanthus altissima.\nt52 Western white pine Pinus monticola.\nt54 Russian olive Elaeagnus angustifolia.\nt55 Scotch broom Cytisus scoparius.\nt56 Bayberry Myrica cerifera.\nt57 Red cedar Juniperus virginiana.\nt60 Western juniper Juniperus occidentalis.\nt61 Sycamore Platanus occidentalis.\nt70 Mulberry (white mulberry) Morus alba.\nt71 Red mulberry Morus rubra.\nt72 Queen palm Arecastrum romanzoffiamon.\nt73 Australian pine Casuarina equisetifolia.\nt77 Oak mix (red, white, black) Quercus spp.\nt80 Japanese cypress Chamaecyparis obtusa.\nt81 Japanese alder Alnus japonica.\nt83 Mango tree Mangifera indica.\nt90 Walnut, black Juglans nigra.\nt96 Poplar, white (poplar) Populus alba.\nt103/t218 Virginia live oak (live oak) Quercus virginiana.\nt105 Pepper tree Schinus molle.\nt110 Orange tree Citrus sinensis.\nt201 Spruce, Norway spruce Picea abies (Picea excelsa).\nt202 Alder, smooth Alnus incana spp. Rugosa (Alnus rugosa).\nt203 Horse chestnut Aesculus hippocastanum.\nt205 Elder Sambucus nigra.\nt206 Chestnut Castanea sativa.\nt207 Douglas fir Pseudotsuga menziesii (Pseudotsuga taxifolia).\nt208 Linden Tilia cordata.\nt209 Horn beam Carpinus betulus.\nt210 Privet Ligustrum vulgare.\nt211 Sweet gum Liquidambar styraciflua.\nt212 Cedar Libocedrus decurrens.\nt213 Pine Pinus radiata.\nt214 Date palm Phoenix canariensis.\nt215 Lilac Syringa vulgaris.\nt217 Pepper tree Schinus molle.\nt217 Red alder Alnus rubra.\nt218 Virginia live oak Quercus virginiana.\nt218 Bayberry (bayberry/sweet gale) Myrica gale.\nt219 Palo verde Cercidium floridum.\nt219 Red cedar Juniperus virginiana.\nt220 Bet v 4 Betula verrucosa (Birch).\nt221 Bet v 2.0101, Bet v 4 Betula verrucosa (Birch).\nt222 Cypress (Arizona cypress) Cupressus arizonica.\nt223 Oil palm Elaeis guineensis.\nt224 Ole e 1 Olea europaea.\nt225 Bet v 6 Betula verrucosa (Birch).\nt226 Cup a 1 Cupressus arizonica.\nt227 Ole e 7 Olea Europaea.\nt228 Aspen, quaking Populus tremuloides.\nt229 Eastern hemlock Tsuga canadensis.\nt230 Redwood (sequoia) Sequoia sempervirens.\nt232 Pussy willow Salix discolor.\nt240 Ole e 9.0101 Olea Europaea.\nt241 Pla a 1.0101 Platanus acerifolia.\nt242 Pla a 2 Platanus acerifolia.\nt243 Pla a 3.0101 Platanus acerifolia.\nt244 Cor a 1.0103 Corylus avellana.\nt245 Aln g 1.0101 Alnus glutinosa.\nt246 Cry j 1 Cryptomeria japonica.\nt280 Locust tree Robinia pseudoacacia.\nt401 Brazilian peppertree Schinus terebinthifolius.\nt402 Mastic tree Pistacia lentiscus.\nt404 Tree of heaven Ailanthus altissima.\nt406 Date palm Phoenix dactylifera.\na482 Ole e 1 Olea europaea (Olive Oil).\nMites\nd207 Blo t 5.0101 Blomia tropicalis.\nd208 Lep d 2.0101 Lepidoglyphus destructor.\nMicroorganisms, Molds, Yeast\nm1 Penicillium chrysogenum (Penicillium notatum) Penicillium chrysogenum (Penicillium notatum).\nm2 Cladosporium herbarum (Hormodendrum) Cladosporium herbarum (Hormodendrum).\nm3 Aspergillus fumigatus Aspergillus fumigatus.\nm4 Mucor racemosus Mucor racemosus.\nm5 Candida albicans Candida albicans.\nm7 Botrytis cinerea Botrytis cinerea.\nm8 Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum) Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes.\nm9 Fusarium moniliforme (Fusarium proliferatum) Fusarium moniliforme (Fusarium proliferatum).\nm10 Stemphylium botryosum Stemphylium herbarum (Stemphylium botryosum).\nm11 Rhizopus nigricans Rhizopus nigricans.\nm12 Aureobasidium pullulans Aureobasidium pullulans.\nm13 Phoma betae Phoma betae.\nm14 Epicoccum purpurascens Epicoccum purpurascens (Epicoccum nigrum).\nm15 Trichoderma viride Trichoderma viride.\nm16 Curvularia lunata Curvularia lunata, Curvularia specifera (K923044).\nm17 Cladosporium fulvum Cladosporium fulvum.\nm18 Fusarium culmorum Fusarium culmorum.\nm19 Aspergillus versicolor Aspergillus versicolor.\nm20 Mucor mucedo Mucor mucedo.\nm21 Aspergillus clavatus Aspergillus clavatus.\nm22 Micropolyspora faeni Saccharopolyspora rectivirgula (Micropolyspora faeni).\nm23 Thermoactinomyces vulgaris Thermoactinomyces vulgaris.\nm24 Stachybotrys atra Stachybotrys chartarum (Stachybotrys atra).\nm24 Paecilomyces spp Paecilomyces spp.\nm25 Aspergillus versicolor Aspergillus versicolor.\nm25 Penicillium brevicompactum Penicillium brevicompactum.\nm26 Cladosporium cladosporioides Cladosporium cladosporioides.\nm26 Penicillium citrinum Penicillium citrinum.\nm27 Penicillium spp Penicillium spp.\nm29 Aspergillus repens Aspergillus repens.\nm30 Penicillium roqueforti Penicillium roqueforti.\nm32 Cladosporium cladosporioides Cladosporium cladosporioides.\nm34 Serpula lacrymans Serpula lacrymans.\nm36 Aspergillus terreus Aspergillus terreus.\nm37 Trichophyton mentagrophytes Trichophyton mentagrophytes.\nm40 Aspergillus amstelodami Aspergillus amstelodami.\nm43 Saccharomyces Carlsberg Saccharomyces carlsbergensis.\nm44 Saccharomyces cerevisiae Saccharomyces cerevisiae.\nm45 Hormodendrum hordei Hormodendrum hordei.\nm46 Bipolaris spicifera Bipolaris spicifera.\nm47 Aspergillus nidulans Aspergillus nidulans.\nm48 Aspergillus oryzae Aspergillus oryzae.\nm49 Fusarium oxysporum Fusarium oxysporum.\nm50 Micropolyspora faeni Saccharopolyspora rectivirgula (Micropolyspora faeni).\nm51 Thermoactinomyces vulgaris Thermoactinomyces vulgaris.\nm53 Microspora canis Microsporum canis (Microspora canis).\nm54 Aspergillus flavus Aspergillus flavus.\nm63 Helminthosporium intersemin Helminthosporium intersemin.\nm66 Mucor plumbeus Mucor plumbeus.\nm67 Mycogone Mycogone perniciosa.\nm68 Nigrospora oryzae Nigrospora oryzae.\nm69 Rhodotorula Rhodotorula rubra (Rhodotorula mucilaginosa).\nm70 Malassezia furfur (Pityrosporum orbiculare) Malassezia furfur (Pityrosporum orbiculare).\nm71 Spondylocladium Spondylocladium spp.\nm72 Epidermophyton Epidermophyton floccosum.\nm73 Epicoccum nigrum Epicoccum purpurascens (Epicoccum nigrum).\nm80 Staphylococcal enterotoxin A (Sta a SEA) Staphylococcus aureus.\nm80 Helminthosporium spp Helminthosporium spp.\nm81 Staphylococcal enterotoxin B (Sta a SEB) Staphylococcus aureus.\nm88 Stemphylium solani Stemphylium solani.\nm93 Gliocladium fimbriatum Gliocladium fimbriatum.\nm94 Phycomyces blakesleeanus Phycomyces blakesleeanus.\nm201 Tilletia tritici (Ustilago nuda, Ustilago tritici) (Barley smut) Tilletia tritici (Ustilago nuda, Ustilago tritici).\nm202 Acremonium kiliense (Cephalosporium acremonium) Acremonium kiliense (Cephalosporium acremonium).\nm203 Trichosporon pullulans Trichosporon pullulans.\nm204 Ulocladium chartarum Ulocladium chartarum.\nm205 Trichophyton rubrum Trichophyton rubrum.\nm207 Aspergillus niger Aspergillus niger.\nm208 Chaetomium globosum Chaetomium globosum.\nm209 Penicillium frequentans Penicillium glabrum (Penicillium frequentans).\nm209 Stachybotrys chartarum Stachybotrys chartarum (Stachybotrys atra).\nm210 Trichophyton mentagrophytes var. goetzii Trichophyton mentagrophytes var. goetzii.\nm211 Trichophyton mentagrophytes var. interdigitale Trichophyton mentagrophytes var. interdigitale.\nm211 Oat smut Ustilago avenae.\nm212 Micropolyspora faeni Saccharopolyspora rectivirgula (Micropolyspora faeni).\nm212 Geotrichum candidum Geotrichum candidum.\nm213 Bermuda grass smut Ustilago cynodontis.\nm214 Johnson grass smut Sphacelotheca cruenta.\nm215 Corn smut Ustilago maydis.\nm218 Asp f 1.0101 Aspergillus fumigatus.\na3050 Asp r 1 Aspergillus restrictus.\nm219 Asp f 2 Aspergillus fumigatus.\nm220 Asp f 3.0101 Aspergillus fumigatus.\nm221 Asp f 4 Aspergillus fumigatus.\nm222 Asp f 6.0101 Aspergillus fumigatus.\nm223 Staphylococcal enterotoxin C (Sta a SEC) Staphylococcus aureus.\nm224 Staphylococcal enterotoxin D (Sta a SED) Staphylococcus aureus.\nm226 Staphylococcal enterotoxin TSST (Sta a TSST) Staphylococcus aureus.\nm227 Malassezia spp. (Pityrosporum spp.) Malassezia spp. (Pityrosporum spp.).\nm228 Aspergillus flavus.\nm229 Alt a 1.0101 Alternaria alternata (Alternaria tenuis).\nm230 Alt a 6.0101 Alternaria alternata (Alternaria tenuis).\nm231 Cla h 8.0101 Cladosporium herbarum (Hormodendrum).\nm300 Eurotium spp Eurotium spp.\nm304 Aspergillus oryzae Aspergillus oryzae.\nm305 Penicillium brevicompactum Penicillium brevicompactum.\nm309 Aspergillus terreus Aspergillus terreus.\nm310 Aspergillus nidulans Aspergillus nidulans.\nm311 Aspergillus flavus Aspergillus flavus.\nm312 Aspergillus clavatus Aspergillus clavatus.\nEpidermal \u0026 Animal\ne6 Guinea pig epithelium Cavia porcellus.\ne7 Pigeon droppings Columba palumbus, Columba livia.\ne25 Chicken serum Gallus domesticus (Gallus gallus domesticus; Gallus spp.).\ne26 Parrot serum Psittacoidea spp.\ne62 Camel Camelus dromedaries.\ne70 Goose feathers Anser anser.\ne71 Mouse epithelium Mus musculus (Mus spp.).\ne73 Rat epithelium Rattus norvegicus.\ne74 Rat urine proteins Rattus norvegicus, Rattus rattus.\ne75 Rat serum proteins Rattus norvegicus, Rattus rattus.\ne76 Mouse serum proteins Mus musculus (Mus spp.).\ne77 Budgerigar droppings Melopsittacus undulatus.\ne78 Budgerigar feathers Melopsittacus undulatus.\ne79 Budgerigar serum proteins Melopsittacus undulatus.\ne80 Goat epithelium Capra hircus.\ne81 Sheep epithelium Ovis aries (Ovis spp.).\ne82 Rabbit epithelium Oryctolagus cuniculus (Oryctolagus spp.).\ne83 Swine epithelium Sus scrofa (Sus scrofa domesticus; Sus spp.).\ne84 Hamster epithelium Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus.\ne85 Chicken feathers Gallus domesticus (Gallus gallus domesticus; Gallus spp.).\ne86 Duck feathers Anas platyrhynchos.\ne87 Rat epithelium, serum proteins, and urine proteins Rattus norvegicus Rattus rattus.\ne88 Mouse epithelium, serum proteins, and urine proteins (mouse) Mus musculus (Mus spp.).\ne89 Turkey feathers Meleagris gallopavo.\ne90 Budgerigar serum proteins, feathers, and droppings Melopsittacus undulatus.\ne91 Pigeon serum proteins, feathers, and droppings Streptopelia roseogrisea, Psittacidae spp.\ne92 Parrot serum proteins, feathers, and droppings Ara spp.\ne93 Pigeon serum proteins Streptopelia roseogrisea.\ne94 Fel d 1.0101 Felis domesticus.\na345 Fel d 1 Felis domesticus.\ne98 Parrot droppings Psittacoidea spp.\ne101 Can f 1.0101 Canis familiaris (Canis domesticus).\na174 Can f 1 Canis familiaris (Canis domesticus).\ne102 Can f 2.0101 Canis familiaris (Canis domesticus).\ne196 Parakeet feathers Nymphicus hollandicus.\ne197 Parakeet droppings Nymphicus hollandicus.\ne198 Parakeet serum Nymphicus hollandicus.\ne199 Canary bird serum Serinus canarius.\ne200 Canary bird droppings Serinus canarius.\ne201 Canary bird feathers (Canary feathers) Serinus canarius.\ne202 Reindeer epithelium Rangifer tarandus.\ne203 Mink epithelium Mustela spp.\ne204 Bos d 6 Bos domesticus (Bos taurus; Bos spp.).\ne205 Horse, serum proteins Equus caballus (Equus spp.).\ne206 Rabbit, serum proteins Oryctolagus cuniculus (Oryctolagus spp.).\ne208 Chinchilla epithelium Chinchilla laniger.\ne209 Gerbil epithelium Meriones unguiculatus.\ne210 Fox epithelium Vulpes vulpes.\ne211 Rabbit, urine proteins Oryctolagus cuniculus (Oryctolagus spp.).\ne212 Swine, urine proteins Sus scrofa (Sus scrofa domesticus; Sus spp.).\ne213 Parrot feathers Ara spp.\ne214 Finch feathers Lonchura domestica.\ne215 Pigeon feathers Streptopelia roseogrisea (Streptopelia spp.), Columbia spp.\ne216 Deer epithelium Dama dama.\ne217 Ferret epithelium Mustela putorius.\ne218 Chicken droppings Gallus domesticus (Gallus gallus domesticus; Gallus spp.).\ne219 Chicken, serum proteins Gallus domesticus (Gallus gallus domesticus; Gallus spp.).\ne220 Fel d 2, Cat serum albumin Felis domesticus.\ne221 Can f 3 Canis familiaris (Canis domesticus) (Dog serum albumin).\ne222 Swine serum albumin (Sus s PSA) Sus scrofa (Sus scrofa domesticus; Sus spp.).\ne225 Lovebird feathers Psittacoidea agapomis.\ne226 Can f 5.0101 Canis familiaris.\ne227 Equ c 1.0101 Equus caballus.\ne228 Fel d 4.0101 Felis domesticus.\ne230 Equ c 3 Equus caballus.\ne231 Mus m 1 Mus musculus.\nFood\nf9 Rice Oryza sativa.\nf12 Pea (green pea) Pisum sativum.\nf15 White bean Phaseolus vulgaris.\nf19 Cayenne pepper Capsicum frutescens (Capsicum annum).\nf21 Sugar cane Saccharum officinarum.\nf22 Raspberry Rubus idaeus.\nf26 Pork Sus scrofa (Sus scrofa domesticus; Sus spp.).\nf29 Watermelon Citrullus lanatus (Citrullus vulgaris).\nf31 Carrot Daucus carota.\nf32 Oyster mushroom Pleurotus ostreatus.\nf33 Orange Citrus sinensis.\nf35 Potato Solanum tuberosum.\nf43 Mother's milk Homo sapiens.\nf44 Strawberry Fragaria vesca (Fragaria spp.).\nf45 Yeast, baker's Saccharomyces cerevisiae.\nf46 Pepper, Red Capsicum annuum.\nf47 Garlic Allium sativum.\nf48 Onion Allium cepa.\nf49 Apple Malus x domestica (Malus spp.).\nf51 Bamboo shoot Phyllostachys pubescens.\nf52 Cacao/chocolate Theobroma cacao.\nf54 Sweet potato Ipomoea batatas.\nf55 Common millet Panicum miliaceum.\nf56 Foxtail millet Setaria italica.\nf57 Japanese millet Echinochloa crus-galli.\nf58 Pacific squid Todarodes pacificus.\nf59 Octopus Octopus vulgaris (Octopus spp.).\nf63 Kefir NA.\nf67 Parmesan cheese NA.\nf81 Cheese, cheddar type NA.\nf82 Cheese, mold type NA.\nf83 Chicken Gallus domesticus (Gallus gallus domesticus; Gallus spp.).\nf86 Parsley Petroselinum crispum.\nf87 Melon Cucumis melo Cucumis melo + Citrullus lanatus.\nf88 Mutton (lamb) Ovis aries (Ovis spp.).\nf90 Malt Hordeum vulgare.\nf92 Banana Musa spp.\nf93 Cacao Theobroma cacao.\nf94 Pear Pyrus communis (Pyrus spp.).\nf97 Yam Dioscorea spp. Dioscorea opposita.\nf97 Chamomile tea Matricaria chamomilla.\nf98 Gliadin Triticum aestivum (Triticum spp.).\nf102 Cantaloupe Cucumis melo var. cantalupensis.\nf105 Chocolate Theobroma cacao.\nf109 Cottonseed Gossypium hirsutum.\nf110 Giant radish Raphanus sativus.\nf118 Zucchini Cucurbita pepo.\nf119 Radish Raphanus sativus.\nf120 Venison Capreolus capeolus.\nf121 Pinto bean Phaseolus vulgaris.\nf122 Cheese, American NA.\nf127 Black-eyed pea Vigna unguiculata.\nf131 Black Olive Olea europaea.\nf136 Red beet Beta vulgaris var. conditiva.\nf139 Goat's Cheese Capra aegagrus.\nf140 Bran NA.\nf141 Corn (vegetables) Zea mays.\nf152 Green bell pepper Capsicum annuum.\nf155 Brewer's yeast Saccharomyces carlsbergensis.\nf157 Duck Anas domesticus.\nf158 Goose Anser anser.\nf160 Camembert cheese NA.\nf162 Nectarine Prunus persica var. nucipersica.\nf163 Kohlrabi Brassica oleracea var. gongylodes.\nf65 Perch\nf166 Leek Allium porrum.\nf170 Cheese (Switzerland) (Swiss cheese) NA.\nf174 Fig Ficus carica.\nf177 Cranberry Vaccinium macrocarpon.\nf179 Raisin Vitis spp.\nf182 Lima bean Phaseolus lunatus.\nf198 Flaxseed (bruised grain) Linum usitatissimum.\nf199 Untreated native milk Bos domesticus (Bos taurus; Bos spp.).\nf208 Lemon Citrus limon.\nf209 Grapefruit Citrus paradisi.\nf210 Pineapple Ananas comosus.\nf211 Blackberry Rubus fruticosus.\nf212 Mushroom (champignon) Agaricus hortensis (Agaricus spp.).\nf213 Rabbit Oryctolagus cuniculus (Oryctolagus spp.).\nf214 Spinach Spinacia oleracea.\nf215 Lettuce Lactuca sativa.\nf216 Cabbage Brassica oleracea var. capitata.\nf217 Brussels sprouts Brassica oleracea var. gem.\nf218 Paprika, sweet pepper Capsicum annuum.\nf219 Fennel seed Foeniculum vulgare.\nf219 Sage Salvia officinalis.\nf220 Cinnamon Cinnamomum spp.\nf221 Coffee Coffea spp.\nf222 Tea Camellia sinensis.\nf223 Green olive Olea europaea.\nf225 Summer squash, pumpkin Cucurbita pepo.\nf225 Pumpkin Cucurbita maxima.\nf226 Pumpkin seed Cucurbita pepo.\nf227 Sugar-beet seed Beta vulgaris.\nf229 Safflower Seed Carthamus tinctorius.\nf231 Milk, boiled Bos domesticus (Bos taurus; Bos spp.).\nf234 Vanilla Vanilla planifolia.\nf237 Apricot Prunus armeniaca.\nf241 Gouda cheese NA.\nf242 Cherry Prunus avium.\nf244 Cucumber Cucumis sativus.\nf246 Guar, guar gum Cyamopsis tetragonoloba.\nf247 Honey NA.\nf248 Rosemary Rosmarinus officinalis.\nf254 Plaice Pleuronectes platessa.\nf255 Plum Prunus domestica, Prunus americana.\nf258 Squid Loligo spp.\nf259 Grape Vitis vinifera (Vitis spp.).\nf260 Broccoli Brassica oleracea var. italica (Brassica oleracea var. cultivar).\nf261 Asparagus Asparagus officinalis.\nf262 Aubergine, eggplant Solanum melongena.\nf263 Green pepper Piper nigrum, Capsicum annuum.\nf264 Eel Anguilla anguilla.\nf265 Caraway Carum carvi.\nf265 Cumin Cuminum cyminum.\nf266 Mace Myristica fragrans.\nf267 Cardamon Elettaria cardamomum.\nf268 Clove Syzygium aromaticum.\nf269 Basil Ocimum basilicum.\nf270 Ginger Zingiber officinale.\nf271 Anise Pimpinella anisum.\nf272 Tarragon Artemisia dracunculus.\nf273 Thyme Thymus vulgaris.\nf274 Marjoram Origanum majorana.\nf275 Lovage Levisticum officinale.\nf276 Fennel, fresh Foeniculum vulgare.\nf277 Dill Anethum graveolens.\nf278 Bay leaf Laurus nobilis.\nf279 Chili pepper Capsicum frutescens.\nf280 Black pepper Piper nigrum.\nf281 Curry (Santa Maria) NA.\nf282 Nutmeg Myristica fragrans.\nf283 Oregano Origanum vulgare.\nf284 Turkey meat Meleagris gallopavo.\nf285 Elk/moose meat Alces spp.\nf286 Mare's milk Equus caballus (Equus spp.).\nf287 Red kidney bean Phaseolus vulgaris.\nf288 Blueberry Vaccinium myrtillus (Vaccinium spp.).\nf289 Date Phoenix dactylifera.\nf291 Cauliflower Brassica oleracea var. botrytis.\nf292 Guava Psidium guajava.\nf293 Papaya Carica papaya.\nf294 Passion fruit, Maracuja Passiflora edulis (Passiflora spp.).\nf295 Carambola Averrhoa carambola.\nf296 Carob Ceratonia siliqua.\nf297 Gum Arabic Acacia senegal (Acacia spp.).\nf298 Tragacanth Astragalus spp.\nf299 Sweet chestnut (chestnut) Castanea sativa.\nf300 Pinto bean Phaseolus spp.\nf301 Persimmon (kaki fruit, sharon) Diospyros kaki.\nf302 Mandarin (tangerine, clementine, satsumas) Citrus reticulata.\nf305 Fenugreek Trigonella foenum-graecum.\nf306 Lime Citrus aurantifolia.\nf307 Hake Merluccius merluccius.\nf308 Sardine (pilchard) Sardina pilchardus.\nf310 Blue vetch Lathyrus sativus.\nf311 Megrim Lepidorhombus whiffiagonis.\nf315 Green bean Phaseolus vulgaris.\nf316 Rape seed Brassica napus.\nf317 Coriander Coriandrum sativum.\nf318 Jack fruit Artocarpus heterophyllus.\nf319 Beetroot Beta vulgaris.\nf320 Crayfish Astacus astacus.\nf321 Horse meat Equus caballus (Equus spp.).\nf322 Red currant Ribes sylvestre.\nf324 Hop (fruit cone) Humulus lupulus.\nf325 Saffron Colchicum autumnale.\nf328 Fig Ficus carica.\nf329 Watermelon Citrullus lanatus.\nf330 Rose hip Rosa spp.\nf331 Saffron Crocus sativus.\nf332 Mint Mentha piperita.\nf333 Linseed Linum usitatissimum.\nf336 Jujube Ziziphus jujuba.\nf336 Wine vinegar Vitis vinifera (Vitis spp.).\nf337 Sole Solea solea.\nf337 English sole Parophrys vetulus.\nf338 Wine, white Vitis vinifera (Vitis spp.).\nf339 Allspice Pimenta dioica.\nf339 Wine, red Vitis vinifera (Vitis spp.).\nf341 Cranberry Vaccinium oxycoccus, Vaccinium macrocarpon.\nf342 Olive (black, fresh) Olea europaea.\nf343 Raspberry Rubus idaeus.\nf344 Sage Salvia officinalis.\nf346 Chives Allium schoenoprasum.\nf347 Quinoa Chenopodium quinoa.\nf348 Litchi Litchi chinensis.\nf349 Chum salmon roe Oncorhynchus keta.\nf358 Artichoke Cynara scolymus.\nf360 Yogurt NA.\nf368 Black bass Micropterus dolomieu (Micropterus dolomieui).\nf374 Karaya gum Sterculia urens.\nf375 Horseradish Armoracia rusticana.\nf377 Maple syrup NA.\nf379 Okra Abelmoschus esculentus.\nf382 Beet, sugar Beta vulgaris var. altissima.\nf401 Loquat Eriobotrya japonica.\nf402 Fig Ficus carica.\nf403 Brewer's yeast Saccharomyces cerevisiae.\nf405 Mint Mentha spp.\nf406 Arugula Eruca vesicaria.\nHouse Dust\nh1 Greer Labs., Inc NA.\nh2 Hollister-Stier Labs NA.\nh6 Japan NA.\nVenoms \u0026 Insects\ni7 Midge Chironomus yoshimatsui.\ni8 Moth Bombyx mori, Heterocera spp.\ni47 Water flea Daphnia spp.\ni49 Deer fly Chrysops spp.\ni51 Black ant Camponotus pennsylvanicus.\ni54 Flea mix (dog/cat), common flea Ctenocephalides spp.\ni71 Mosquito Aedes communis, Aedes spp. and Culex spp.\ni72 Green nimitti Cladotanytarsus lewisi.\ni73 Blood worm Chironomus thummi, Chironomusri parius, Chironomus spp.\ni75 European hornet Vespa crabro.\ni76 Berlin beetle Trogoderma angustum.\ni77 European paper wasp Polistes dominulus.\ni78 Fly Musca domestica.\ni80 Bumblebee Bombus pennsylvanicus.\ni201 Horse bot fly Gasterophilus intestinalis.\ni202 Grain weevil Sitophilus granarius.\ni203 Mediterranean flour moth Ephestia kuehniella (Anagasta kuehniella).\ni204 Horse fly Tabanus spp.\ni205 Bumblebee Bombus terrestris.\ni208 Api m 1.0101 Apis mellifera.\na45 Api m 1 Apis mellifera.\ni209 Ves v 5.0101 Vespula vulgaris.\na670 Ves v 5 Vespula vulgaris.\ni210 Pol d 5.0101 Polistes dominulus.\ni211 Ves v 1.0101 Vespula vulgaris.\ni213 Api m 4 Apis mellifera.\ni214 Api m 2 Apis mellifera.\ni215 Api m 3 Apis mellifera.\ni216 Api m 5 Apis mellifera.\ni217 Api m 10 Apis mellifera.\ni220 Bla g 1.0101 Blattella germanica.\ni221 Bla g 2.0101 Blattella germanica.\ni222 Bla g 5.0101 Blattella germanica.\ni223 Bla g 7 Blattella germanica.\na46 Api m 2 Apis mellifera.\nMiscellaneous\no1 Cotton, crude fibers Gossypium spp.\no3 Cotton (treated) Gossypium spp.\no70 Seminal fluid Homo sapiens.\no71 Staphylococcus aureus Staphylococcus aureus.\no72 Pichia pastoris crude extract customer specific Pichia pastoris.\no72 Sperm-sediment Homo sapiens.\no73 Pichia pastoris crude extr. vector customer specific Pichia pastoris.\no74 Pichia pastoris with vector customer specific Pichia pastoris.\no201 Tobacco leaf, tobacco dust Nicotiana tabacum.\no202 Artemia salina, fish feed Artemia salina.\no203 Tetramin, fish feed NA.\no207 Daphnia, fish feed Daphnia spp.\no211 Mealworm Tenebrio molitor.\no212 Streptavidin Streptomyces avidini.\no213 MBP (maltose binding protein) Escherichia coli.\no214 CCD; MUXF3 from bromelain Ananas comosus.\no72 Enterotoxin A (Sta a SEA) Staphylococcus aureus.\no73 Enterotoxin B (Sta a SEB) Staphylococcus aureus.\nParasites\np1 Ascaris Ascaris suum.\np2 Echinococcus Echinococcus granulosus.\np3 Schistosoma Schistosoma mansoni.\np4 Anisakis (Herring Worm) Anisakis simplex (Anisakis spp.).\np5 Toxocara canis Toxocara canis.\np10 Ani s 3.0101 Anisakis simplex (Anisakis spp.).\np11 Ani s 1 Anisakis simplex (Anisakis spp.).\nOccupational\nk4 Threshing dust NA.\nk5 Flax NA.\nk7 Hay Dust NA.\nk8 Hop (hops) Humulus lupulus.\nk12 Grain mill dust NA.\nk14 Kapok NA.\nk20 Sheep's wool (treated) (wool) Ovis aries (Ovis spp.).\nk21 Sheep's wool (Untreated) Ovis aries (Ovis spp.).\nk23 Straw Dust NA.\nk33 Oak NA.\nk70 Green coffee bean Coffea spp.\nk71 Castor bean Ricinus communis.\nk72 Ispaghula Plantago psyllium/Plantago ovata.\nk73 Silk waste NA.\nk74 Silk Bombyx mori.\nk75 Isocyanate TDI (Toluene diisocyanate) NA.\nk76 Isocyanate MDI (Diphenylmethane diisocyanate) NA.\nk77 Isocyanate HDI (Hexamethylen diisocyanate) NA.\nk78 Ethylene oxide NA.\nk79 Phthalic anhydride NA.\nk80 Formaldehyde/Formalin NA.\nk81 Ficus Ficus benjamina (Ficus spp.).\nk83 Cotton seed Gossypium hirsutum.\nk84 Sunflower seed Helianthus annuus.\nk85 Chloramin T NA.\nk86 Trimellitic anhydride, TMA NA.\nk87 Asp o 21, alpha-amylase Aspergillus oryzae.\nk89 Orris root Iris florentina.\nk99 HSA (Human Serum Albumin) (Hom s HSA) Homo sapiens.\nk201 Car p 1, Papain Carica papaya.\nk202 Ana c 2, Bromelain Ananas comosus.\nk204 Maxatase Bacillus licheniformis.\nk205 Alcalase Bacillus spp.\nk206 Savinase, Protease 1 (Bac l Subtilisin) Bacillus spp.\nk208 Gal d 4, Lysozyme Gallus domesticus (Gallus gallus domesticus; Gallus spp.).\nk209 Hexahydrophtalic anhydrid NA.\nk210 Maleic anhydride NA.\nk211 Methyltetrahydrophtalic anhydrid NA.\nk212 Abachi wood dust Triplochiton scleroxylon.\nk213 Pepsin (Sus s Pepsin) Sus scrofa (Sus scrofa domesticus; Sus spp.).\nk213 TCPA NA.\nk214 Bougainvillea Bougainvillea spp.\nk225 Horse radish peroxidase (Arm r HRP) Armoracia rusticana.\nk226 Ascorbate oxidase (Cuc p ascorbate oxidase) Cucurbita pepo.\nk301 Flour dust Triticum spp.\nk501 Savinase customer specific Proprietary knowledge of customer.\nk502 Lipolase customer specific Proprietary knowledge of customer.\nk503 Termamyl customer specific Proprietary knowledge of customer.\nk504 Clazinase customer specific Proprietary knowledge of customer.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES","Subpart F—Immunological Test Systems"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"2e48dc7b933c8952f9d4ce3660aef7f019a39057cc700bab5a1a5d1a3999c275","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5735","next":"us/21-cfr-866.5760"},"notice":"GroundRules: Original legal text. Not legal advice."}