21 C.F.R. § 866.5750

Current through November 30, 2024

Section 866.5750 - Radioallergosorbent (RAST) immunological test system

(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.

(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 .

Table 1-Class II Exempt Allergens Under § 866.5750 -Radioallergosorbent (RAST) Immunological Test Systems

Allergen code	Allergen product	Source (taxonomical name)
Grass Pollens
g1	Sweet vernal grass	Anthoxanthum odoratum.
g3	Cocksfoot grass, Orchard grass	Dactylis glomerata.
g4	Meadow fescue	Festuca elatior.
g5	Rye-grass (perennial rye grass)	Lolium perenne.
g7	Common reed (common reed grass)	Phragmites communis.
g8	Meadow grass, Kentucky blue (June grass)	Poa pratensis.
g9	Redtop, Bentgrass	Agrostis stolonifera, Agrostis gigantea (Agrostis alba).
g11	Brome grass	Bromus inermis.
g12	Cultivated rye (cultivated rye grass)	Secale cereale.
g13	Velvet grass	Holcus lanatus.
g14	Cultivated oat (cultivated oat grass)	Avena sativa.
g15	Cultivated wheat (cultivated wheat grass)	Triticum aestivum (Triticum spp.).
g16	Meadow foxtail (meadow foxtail grass)	Alopecurus pratensis.
g17	Bahia grass	Paspalum notatum.
g24	Wheat grass, Western	Agropyron smithii (Elymus smithii).
g30	Bluegrass, annual	Poa annua.
g70	Wild rye grass	Elymus triticoidesElymus condensatus.
g71	Canary grass	Phalaris arundinacea.
g201	Barley, cultivated	Hordeum vulgare.
g202	Maize, corn (cultivated corn)	Zea mays.
g203	Salt grass	Distichlis spicata.
g204	False oat-grass	Arrhenatherum elatius.
g216	Cyn d 1	Cynodon dactylon.
g701	Phl p 1.0102, Phl p 5.0101	Phleum pratense.
g702	Phl p 7.0101	Phleum pratense.
g703	Phl p 12.0101	Phleum pratense.
Weed Pollens
w2	Western ragweed	Ambrosia psilostachya.
w4	False ragweed	Ambrosia acanthicarpa (Franseria acanthicarpa).
w5	Wormwood	Artemisia absinthiumArtemisia annua.
w6	Mugwort	Artemisia vulgaris.
w7	Marguerite, ox-eye daisy	Chrysanthemum leucanthemum.
w8	Dandelion	Taraxacum vulgare, Taraxacum officinale.
w9	Plantain (English), Ribwort	Plantago lanceolata.
w10	Goosefoot, lamb's quarters	Chenopodium album.
w11	Saltwort (prickly), Russian thistle	Salsola kali (Salsola pestifer).
w12	Goldenrod	Solidago virgaurea (Solidago spp.).
w13	Cocklebur, common	Xanthium commune.
w14	Common pigweed (rough pigweed)	Amaranthus retroflexus.
w15	Scale, Lenscale	Atriplex lentiformis.
w16	Rough marsh elder	Iva ciliate, Iva annua.
w17	Firebush (Kochia)	Kochia scoparia.
w18	Sheep sorrel	Rumex acetosella.
w19	Wall pellitory	Parietaria officinalis.
w20	Nettle (Common stinging nettle)	Urtica dioica.
w21	Wall pellitory	Parietaria judaica.
w22	Japanese hop (careless weed)	Humulus japonicas (Humulus scandens).
w23	Yellow dock, Yellow dockweed	Rumex crispus.
w24	Spiny pigweed	Amaranthus spinosus.
w27	Carnation	Dianthus spp.
w28	Rose	Rosa rugosa.
w33	Clover	Trifolium pratense.
w35	Mexican tea	Chenopodium ambrosioides.
w36	Rabbit bush	Ambrosia deltoidea (Franseria deltoides).
w37	Salt bush, annual	Atriplex wrightii.
w39	Water hemp, Western	Amaranthus rudis (Acnida tamariscina).
w41	Burrobrush	Hymenoclea salsola.
w42	Poverty weed	Baccharis neglecta.
w43	Common sagebrush	Artemisia tridentata.
w45	Alfalfa	Medicago sativa.
w46	Dog fennel	Eupatorium capillifolium.
w53	Geranium	Geranium spp.
w67	Groundsel bush	Baccharis halimifolia.
w69	Iodine bush	Allenrolfea occidentalis.
w70	Ragweed, slender	Ambrosia confertiflora.
w75	Wing scale (wingscale)	Atriplex canescens.
w82	Careless weed	Amaranthus palmeri, Amaranthus hybridus.
w90	Japanese hop	Humulus japonicas (Humulus scandens).
w203	Rape (rape pollen)	Brassica napus.
w204	Sunflower	Helianthus annuus.
w206	Camomile	Matricaria chamomilla.
w207	Lupin	Lupinus spp.
w210	Sugar-beet	Beta vulgaris.
w211	Par j 2.0101	Parietaria judaica.
w231	Art v 1	Artemisia vulgaris (Mugwort).
w232	Sal k 1	Salsola kali.
w233	Art v 3	Artemisa vulgaris (LTP, Mugwort).
w234	Pla l 1	Plantago lanceolata.
w235	Che a 1.0101	Chenopodium album.
w236	Mer a 1.0101	Mercurialis annua.
a753	Art v 1	Artemisia vulgaris (Mugwort weed).
Tree Pollens
t1	Box-elder (Maple)	Acer negundo, Acer saccharum.
t2	Gray alder, speckled alder (alder)	Alnus incana.
t4	Hazel, hazelnut	Corylus avellana, Corylus americana.
t5	American beech (beech)	Fagus grandifolia (Fagus americana).
t6	Mountain juniper, Mountain cedar	Juniperus ashei (Juniperus sabinoides).
t8	Elm	Ulmus americana.
t9	Olive	Olea europaea.
t10	Walnut	Juglans californica, Juglans nigra.
t11	Maple leaf sycamore, London plane, Plane tree	Platanus acerifolia.
t61	Sycamore	Platanus occidentalis.
t12	Willow	Salix caprea, Salix nigra.
t14	Cottonwood (Eastern Cottonwood/Black Cottonwood)	Populus deltoides.
t15	White ash	Fraxinus americana.
t16	White pine	Pinus strobus.
t18	Eucalyptus, gum-tree	Eucalyptus globulus (Eucalyptus spp.).
t19/t26	Acacia	Acacia longifolia (Acacia spp.).
t20	Mesquite	Prosopis glandulosa/Prosopis juliflora.
t21	Melaleuca, cajeput tree	Melaleuca quinquenervia (Melaleuca leucadendron).
t22	Pecan, hickory	Carya illinoinensis (Carya pecan).
t23	Italian/Mediterranean/funeral cypress	Cupressus sempervirens.
t24	Japanese cypress	Chamaecyparis obtusa (Chamaecyparis spp.).
t25	Ash	Fraxinus excelsior.
t27	Maple, red	Acer rubrum.
t29	Acacia	Acacia spp.
t30	Birch, white	Betula populifolia.
t32	Willow, black	Salix nigra.
t33	Ash, Arizona	Fraxinus velutina.
t35	Cedar, salt	Tamarix gallica.
t37	Bald cypress (white bald cypress)	Taxodium distichum.
t38	Elm, Chinese/Siberian	Ulmus pumila.
t40	Hazelnut tree	Corylus americana.
t41	White hickory	Carya alba (Carya tomentosa).
t42	Oak, red	Quercus rubra.
t43	Loblolly pine	Pinus taeda.
t44	Hackberry	Celtis occidentalis.
t45	Cedar elm	Ulmus crassifolia.
t47	Juniper, one seed	Juniperus monosperma.
t48	Pine, lodgepole	Pinus contorta.
t49	Pine, ponderosa	Pinus ponderosa.
t50	Beech, European	Fagus sylvatica.
t51	Tree of Heaven	Ailanthus altissima.
t52	Western white pine	Pinus monticola.
t54	Russian olive	Elaeagnus angustifolia.
t55	Scotch broom	Cytisus scoparius.
t56	Bayberry	Myrica cerifera.
t57	Red cedar	Juniperus virginiana.
t60	Western juniper	Juniperus occidentalis.
t61	Sycamore	Platanus occidentalis.
t70	Mulberry (white mulberry)	Morus alba.
t71	Red mulberry	Morus rubra.
t72	Queen palm	Arecastrum romanzoffiamon.
t73	Australian pine	Casuarina equisetifolia.
t77	Oak mix (red, white, black)	Quercus spp.
t80	Japanese cypress	Chamaecyparis obtusa.
t81	Japanese alder	Alnus japonica.
t83	Mango tree	Mangifera indica.
t90	Walnut, black	Juglans nigra.
t96	Poplar, white (poplar)	Populus alba.
t103/t218	Virginia live oak (live oak)	Quercus virginiana.
t105	Pepper tree	Schinus molle.
t110	Orange tree	Citrus sinensis.
t201	Spruce, Norway spruce	Picea abies (Picea excelsa).
t202	Alder, smooth	Alnus incana spp. Rugosa (Alnus rugosa).
t203	Horse chestnut	Aesculus hippocastanum.
t205	Elder	Sambucus nigra.
t206	Chestnut	Castanea sativa.
t207	Douglas fir	Pseudotsuga menziesii (Pseudotsuga taxifolia).
t208	Linden	Tilia cordata.
t209	Horn beam	Carpinus betulus.
t210	Privet	Ligustrum vulgare.
t211	Sweet gum	Liquidambar styraciflua.
t212	Cedar	Libocedrus decurrens.
t213	Pine	Pinus radiata.
t214	Date palm	Phoenix canariensis.
t215	Lilac	Syringa vulgaris.
t217	Pepper tree	Schinus molle.
t217	Red alder	Alnus rubra.
t218	Virginia live oak	Quercus virginiana.
t218	Bayberry (bayberry/sweet gale)	Myrica gale.
t219	Palo verde	Cercidium floridum.
t219	Red cedar	Juniperus virginiana.
t220	Bet v 4	Betula verrucosa (Birch).
t221	Bet v 2.0101, Bet v 4	Betula verrucosa (Birch).
t222	Cypress (Arizona cypress)	Cupressus arizonica.
t223	Oil palm	Elaeis guineensis.
t224	Ole e 1	Olea europaea.
t225	Bet v 6	Betula verrucosa (Birch).
t226	Cup a 1	Cupressus arizonica.
t227	Ole e 7	Olea Europaea.
t228	Aspen, quaking	Populus tremuloides.
t229	Eastern hemlock	Tsuga canadensis.
t230	Redwood (sequoia)	Sequoia sempervirens.
t232	Pussy willow	Salix discolor.
t240	Ole e 9.0101	Olea Europaea.
t241	Pla a 1.0101	Platanus acerifolia.
t242	Pla a 2	Platanus acerifolia.
t243	Pla a 3.0101	Platanus acerifolia.
t244	Cor a 1.0103	Corylus avellana.
t245	Aln g 1.0101	Alnus glutinosa.
t246	Cry j 1	Cryptomeria japonica.
t280	Locust tree	Robinia pseudoacacia.
t401	Brazilian peppertree	Schinus terebinthifolius.
t402	Mastic tree	Pistacia lentiscus.
t404	Tree of heaven	Ailanthus altissima.
t406	Date palm	Phoenix dactylifera.
a482	Ole e 1	Olea europaea (Olive Oil).
Mites
d207	Blo t 5.0101	Blomia tropicalis.
d208	Lep d 2.0101	Lepidoglyphus destructor.
Microorganisms, Molds, Yeast
m1	Penicillium chrysogenum (Penicillium notatum)	Penicillium chrysogenum (Penicillium notatum).
m2	Cladosporium herbarum (Hormodendrum)	Cladosporium herbarum (Hormodendrum).
m3	Aspergillus fumigatus	Aspergillus fumigatus.
m4	Mucor racemosus	Mucor racemosus.
m5	Candida albicans	Candida albicans.
m7	Botrytis cinerea	Botrytis cinerea.
m8	Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum)	Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes.
m9	Fusarium moniliforme (Fusarium proliferatum)	Fusarium moniliforme (Fusarium proliferatum).
m10	Stemphylium botryosum	Stemphylium herbarum (Stemphylium botryosum).
m11	Rhizopus nigricans	Rhizopus nigricans.
m12	Aureobasidium pullulans	Aureobasidium pullulans.
m13	Phoma betae	Phoma betae.
m14	Epicoccum purpurascens	Epicoccum purpurascens (Epicoccum nigrum).
m15	Trichoderma viride	Trichoderma viride.
m16	Curvularia lunata	Curvularia lunata, Curvularia specifera (K923044).
m17	Cladosporium fulvum	Cladosporium fulvum.
m18	Fusarium culmorum	Fusarium culmorum.
m19	Aspergillus versicolor	Aspergillus versicolor.
m20	Mucor mucedo	Mucor mucedo.
m21	Aspergillus clavatus	Aspergillus clavatus.
m22	Micropolyspora faeni	Saccharopolyspora rectivirgula (Micropolyspora faeni).
m23	Thermoactinomyces vulgaris	Thermoactinomyces vulgaris.
m24	Stachybotrys atra	Stachybotrys chartarum (Stachybotrys atra).
m24	Paecilomyces spp	Paecilomyces spp.
m25	Aspergillus versicolor	Aspergillus versicolor.
m25	Penicillium brevicompactum	Penicillium brevicompactum.
m26	Cladosporium cladosporioides	Cladosporium cladosporioides.
m26	Penicillium citrinum	Penicillium citrinum.
m27	Penicillium spp	Penicillium spp.
m29	Aspergillus repens	Aspergillus repens.
m30	Penicillium roqueforti	Penicillium roqueforti.
m32	Cladosporium cladosporioides	Cladosporium cladosporioides.
m34	Serpula lacrymans	Serpula lacrymans.
m36	Aspergillus terreus	Aspergillus terreus.
m37	Trichophyton mentagrophytes	Trichophyton mentagrophytes.
m40	Aspergillus amstelodami	Aspergillus amstelodami.
m43	Saccharomyces Carlsberg	Saccharomyces carlsbergensis.
m44	Saccharomyces cerevisiae	Saccharomyces cerevisiae.
m45	Hormodendrum hordei	Hormodendrum hordei.
m46	Bipolaris spicifera	Bipolaris spicifera.
m47	Aspergillus nidulans	Aspergillus nidulans.
m48	Aspergillus oryzae	Aspergillus oryzae.
m49	Fusarium oxysporum	Fusarium oxysporum.
m50	Micropolyspora faeni	Saccharopolyspora rectivirgula (Micropolyspora faeni).
m51	Thermoactinomyces vulgaris	Thermoactinomyces vulgaris.
m53	Microspora canis	Microsporum canis (Microspora canis).
m54	Aspergillus flavus	Aspergillus flavus.
m63	Helminthosporium intersemin	Helminthosporium intersemin.
m66	Mucor plumbeus	Mucor plumbeus.
m67	Mycogone	Mycogone perniciosa.
m68	Nigrospora oryzae	Nigrospora oryzae.
m69	Rhodotorula	Rhodotorula rubra (Rhodotorula mucilaginosa).
m70	Malassezia furfur (Pityrosporum orbiculare)	Malassezia furfur (Pityrosporum orbiculare).
m71	Spondylocladium	Spondylocladium spp.
m72	Epidermophyton	Epidermophyton floccosum.
m73	Epicoccum nigrum	Epicoccum purpurascens (Epicoccum nigrum).
m80	Staphylococcal enterotoxin A (Sta a SEA)	Staphylococcus aureus.
m80	Helminthosporium spp	Helminthosporium spp.
m81	Staphylococcal enterotoxin B (Sta a SEB)	Staphylococcus aureus.
m88	Stemphylium solani	Stemphylium solani.
m93	Gliocladium fimbriatum	Gliocladium fimbriatum.
m94	Phycomyces blakesleeanus	Phycomyces blakesleeanus.
m201	Tilletia tritici (Ustilago nuda, Ustilago tritici) (Barley smut)	Tilletia tritici (Ustilago nuda, Ustilago tritici).
m202	Acremonium kiliense (Cephalosporium acremonium)	Acremonium kiliense (Cephalosporium acremonium).
m203	Trichosporon pullulans	Trichosporon pullulans.
m204	Ulocladium chartarum	Ulocladium chartarum.
m205	Trichophyton rubrum	Trichophyton rubrum.
m207	Aspergillus niger	Aspergillus niger.
m208	Chaetomium globosum	Chaetomium globosum.
m209	Penicillium frequentans	Penicillium glabrum (Penicillium frequentans).
m209	Stachybotrys chartarum	Stachybotrys chartarum (Stachybotrys atra).
m210	Trichophyton mentagrophytes var. goetzii	Trichophyton mentagrophytes var. goetzii.
m211	Trichophyton mentagrophytes var. interdigitale	Trichophyton mentagrophytes var. interdigitale.
m211	Oat smut	Ustilago avenae.
m212	Micropolyspora faeni	Saccharopolyspora rectivirgula (Micropolyspora faeni).
m212	Geotrichum candidum	Geotrichum candidum.
m213	Bermuda grass smut	Ustilago cynodontis.
m214	Johnson grass smut	Sphacelotheca cruenta.
m215	Corn smut	Ustilago maydis.
m218	Asp f 1.0101	Aspergillus fumigatus.
a3050	Asp r 1	Aspergillus restrictus.
m219	Asp f 2	Aspergillus fumigatus.
m220	Asp f 3.0101	Aspergillus fumigatus.
m221	Asp f 4	Aspergillus fumigatus.
m222	Asp f 6.0101	Aspergillus fumigatus.
m223	Staphylococcal enterotoxin C (Sta a SEC)	Staphylococcus aureus.
m224	Staphylococcal enterotoxin D (Sta a SED)	Staphylococcus aureus.
m226	Staphylococcal enterotoxin TSST (Sta a TSST)	Staphylococcus aureus.
m227	Malassezia spp. (Pityrosporum spp.)	Malassezia spp. (Pityrosporum spp.).
m228	Aspergillus flavus.
m229	Alt a 1.0101	Alternaria alternata (Alternaria tenuis).
m230	Alt a 6.0101	Alternaria alternata (Alternaria tenuis).
m231	Cla h 8.0101	Cladosporium herbarum (Hormodendrum).
m300	Eurotium spp	Eurotium spp.
m304	Aspergillus oryzae	Aspergillus oryzae.
m305	Penicillium brevicompactum	Penicillium brevicompactum.
m309	Aspergillus terreus	Aspergillus terreus.
m310	Aspergillus nidulans	Aspergillus nidulans.
m311	Aspergillus flavus	Aspergillus flavus.
m312	Aspergillus clavatus	Aspergillus clavatus.
Epidermal & Animal
e6	Guinea pig epithelium	Cavia porcellus.
e7	Pigeon droppings	Columba palumbus, Columba livia.
e25	Chicken serum	Gallus domesticus (Gallus gallus domesticus; Gallus spp.).
e26	Parrot serum	Psittacoidea spp.
e62	Camel	Camelus dromedaries.
e70	Goose feathers	Anser anser.
e71	Mouse epithelium	Mus musculus (Mus spp.).
e73	Rat epithelium	Rattus norvegicus.
e74	Rat urine proteins	Rattus norvegicus, Rattus rattus.
e75	Rat serum proteins	Rattus norvegicus, Rattus rattus.
e76	Mouse serum proteins	Mus musculus (Mus spp.).
e77	Budgerigar droppings	Melopsittacus undulatus.
e78	Budgerigar feathers	Melopsittacus undulatus.
e79	Budgerigar serum proteins	Melopsittacus undulatus.
e80	Goat epithelium	Capra hircus.
e81	Sheep epithelium	Ovis aries (Ovis spp.).
e82	Rabbit epithelium	Oryctolagus cuniculus (Oryctolagus spp.).
e83	Swine epithelium	Sus scrofa (Sus scrofa domesticus; Sus spp.).
e84	Hamster epithelium	Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus.
e85	Chicken feathers	Gallus domesticus (Gallus gallus domesticus; Gallus spp.).
e86	Duck feathers	Anas platyrhynchos.
e87	Rat epithelium, serum proteins, and urine proteins	Rattus norvegicusRattus rattus.
e88	Mouse epithelium, serum proteins, and urine proteins (mouse)	Mus musculus (Mus spp.).
e89	Turkey feathers	Meleagris gallopavo.
e90	Budgerigar serum proteins, feathers, and droppings	Melopsittacus undulatus.
e91	Pigeon serum proteins, feathers, and droppings	Streptopelia roseogrisea, Psittacidae spp.
e92	Parrot serum proteins, feathers, and droppings	Ara spp.
e93	Pigeon serum proteins	Streptopelia roseogrisea.
e94	Fel d 1.0101	Felis domesticus.
a345	Fel d 1	Felis domesticus.
e98	Parrot droppings	Psittacoidea spp.
e101	Can f 1.0101	Canis familiaris (Canis domesticus).
a174	Can f 1	Canis familiaris (Canis domesticus).
e102	Can f 2.0101	Canis familiaris (Canis domesticus).
e196	Parakeet feathers	Nymphicus hollandicus.
e197	Parakeet droppings	Nymphicus hollandicus.
e198	Parakeet serum	Nymphicus hollandicus.
e199	Canary bird serum	Serinus canarius.
e200	Canary bird droppings	Serinus canarius.
e201	Canary bird feathers (Canary feathers)	Serinus canarius.
e202	Reindeer epithelium	Rangifer tarandus.
e203	Mink epithelium	Mustela spp.
e204	Bos d 6	Bos domesticus (Bos taurus; Bos spp.).
e205	Horse, serum proteins	Equus caballus (Equus spp.).
e206	Rabbit, serum proteins	Oryctolagus cuniculus (Oryctolagus spp.).
e208	Chinchilla epithelium	Chinchilla laniger.
e209	Gerbil epithelium	Meriones unguiculatus.
e210	Fox epithelium	Vulpes vulpes.
e211	Rabbit, urine proteins	Oryctolagus cuniculus (Oryctolagus spp.).
e212	Swine, urine proteins	Sus scrofa (Sus scrofa domesticus; Sus spp.).
e213	Parrot feathers	Ara spp.
e214	Finch feathers	Lonchura domestica.
e215	Pigeon feathers	Streptopelia roseogrisea (Streptopelia spp.), Columbia spp.
e216	Deer epithelium	Dama dama.
e217	Ferret epithelium	Mustela putorius.
e218	Chicken droppings	Gallus domesticus (Gallus gallus domesticus; Gallus spp.).
e219	Chicken, serum proteins	Gallus domesticus (Gallus gallus domesticus; Gallus spp.).
e220	Fel d 2, Cat serum albumin	Felis domesticus.
e221	Can f 3	Canis familiaris (Canis domesticus) (Dog serum albumin).
e222	Swine serum albumin (Sus s PSA)	Sus scrofa (Sus scrofa domesticus; Sus spp.).
e225	Lovebird feathers	Psittacoidea agapomis.
e226	Can f 5.0101	Canis familiaris.
e227	Equ c 1.0101	Equus caballus.
e228	Fel d 4.0101	Felis domesticus.
e230	Equ c 3	Equus caballus.
e231	Mus m 1	Mus musculus.
Food
f9	Rice	Oryza sativa.
f12	Pea (green pea)	Pisum sativum.
f15	White bean	Phaseolus vulgaris.
f19	Cayenne pepper	Capsicum frutescens (Capsicum annum).
f21	Sugar cane	Saccharum officinarum.
f22	Raspberry	Rubus idaeus.
f26	Pork	Sus scrofa (Sus scrofa domesticus; Sus spp.).
f29	Watermelon	Citrullus lanatus (Citrullus vulgaris).
f31	Carrot	Daucus carota.
f32	Oyster mushroom	Pleurotus ostreatus.
f33	Orange	Citrus sinensis.
f35	Potato	Solanum tuberosum.
f43	Mother's milk	Homo sapiens.
f44	Strawberry	Fragaria vesca (Fragaria spp.).
f45	Yeast, baker's	Saccharomyces cerevisiae.
f46	Pepper, Red	Capsicum annuum.
f47	Garlic	Allium sativum.
f48	Onion	Allium cepa.
f49	Apple	Malus x domestica (Malus spp.).
f51	Bamboo shoot	Phyllostachys pubescens.
f52	Cacao/chocolate	Theobroma cacao.
f54	Sweet potato	Ipomoea batatas.
f55	Common millet	Panicum miliaceum.
f56	Foxtail millet	Setaria italica.
f57	Japanese millet	Echinochloa crus-galli.
f58	Pacific squid	Todarodes pacificus.
f59	Octopus	Octopus vulgaris (Octopus spp.).
f63	Kefir	NA.
f67	Parmesan cheese	NA.
f81	Cheese, cheddar type	NA.
f82	Cheese, mold type	NA.
f83	Chicken	Gallus domesticus (Gallus gallus domesticus; Gallus spp.).
f86	Parsley	Petroselinum crispum.
f87	Melon	Cucumis melo Cucumis melo + Citrullus lanatus.
f88	Mutton (lamb)	Ovis aries (Ovis spp.).
f90	Malt	Hordeum vulgare.
f92	Banana	Musa spp.
f93	Cacao	Theobroma cacao.
f94	Pear	Pyrus communis (Pyrus spp.).
f97	Yam	Dioscorea spp. Dioscorea opposita.
f97	Chamomile tea	Matricaria chamomilla.
f98	Gliadin	Triticum aestivum (Triticum spp.).
f102	Cantaloupe	Cucumis melo var. cantalupensis.
f105	Chocolate	Theobroma cacao.
f109	Cottonseed	Gossypium hirsutum.
f110	Giant radish	Raphanus sativus.
f118	Zucchini	Cucurbita pepo.
f119	Radish	Raphanus sativus.
f120	Venison	Capreolus capeolus.
f121	Pinto bean	Phaseolus vulgaris.
f122	Cheese, American	NA.
f127	Black-eyed pea	Vigna unguiculata.
f131	Black Olive	Olea europaea.
f136	Red beet	Beta vulgaris var. conditiva.
f139	Goat's Cheese	Capra aegagrus.
f140	Bran	NA.
f141	Corn (vegetables)	Zea mays.
f152	Green bell pepper	Capsicum annuum.
f155	Brewer's yeast	Saccharomyces carlsbergensis.
f157	Duck	Anas domesticus.
f158	Goose	Anser anser.
f160	Camembert cheese	NA.
f162	Nectarine	Prunus persica var. nucipersica.
f163	Kohlrabi	Brassica oleracea var. gongylodes.
f65	Perch
f166	Leek	Allium porrum.
f170	Cheese (Switzerland) (Swiss cheese)	NA.
f174	Fig	Ficus carica.
f177	Cranberry	Vaccinium macrocarpon.
f179	Raisin	Vitis spp.
f182	Lima bean	Phaseolus lunatus.
f198	Flaxseed (bruised grain)	Linum usitatissimum.
f199	Untreated native milk	Bos domesticus (Bos taurus; Bos spp.).
f208	Lemon	Citrus limon.
f209	Grapefruit	Citrus paradisi.
f210	Pineapple	Ananas comosus.
f211	Blackberry	Rubus fruticosus.
f212	Mushroom (champignon)	Agaricus hortensis (Agaricus spp.).
f213	Rabbit	Oryctolagus cuniculus (Oryctolagus spp.).
f214	Spinach	Spinacia oleracea.
f215	Lettuce	Lactuca sativa.
f216	Cabbage	Brassica oleracea var. capitata.
f217	Brussels sprouts	Brassica oleracea var. gem.
f218	Paprika, sweet pepper	Capsicum annuum.
f219	Fennel seed	Foeniculum vulgare.
f219	Sage	Salvia officinalis.
f220	Cinnamon	Cinnamomum spp.
f221	Coffee	Coffea spp.
f222	Tea	Camellia sinensis.
f223	Green olive	Olea europaea.
f225	Summer squash, pumpkin	Cucurbita pepo.
f225	Pumpkin	Cucurbita maxima.
f226	Pumpkin seed	Cucurbita pepo.
f227	Sugar-beet seed	Beta vulgaris.
f229	Safflower Seed	Carthamus tinctorius.
f231	Milk, boiled	Bos domesticus (Bos taurus; Bos spp.).
f234	Vanilla	Vanilla planifolia.
f237	Apricot	Prunus armeniaca.
f241	Gouda cheese	NA.
f242	Cherry	Prunus avium.
f244	Cucumber	Cucumis sativus.
f246	Guar, guar gum	Cyamopsis tetragonoloba.
f247	Honey	NA.
f248	Rosemary	Rosmarinus officinalis.
f254	Plaice	Pleuronectes platessa.
f255	Plum	Prunus domestica, Prunus americana.
f258	Squid	Loligo spp.
f259	Grape	Vitis vinifera (Vitis spp.).
f260	Broccoli	Brassica oleracea var. italica (Brassica oleracea var. cultivar).
f261	Asparagus	Asparagus officinalis.
f262	Aubergine, eggplant	Solanum melongena.
f263	Green pepper	Piper nigrum, Capsicum annuum.
f264	Eel	Anguilla anguilla.
f265	Caraway	Carum carvi.
f265	Cumin	Cuminum cyminum.
f266	Mace	Myristica fragrans.
f267	Cardamon	Elettaria cardamomum.
f268	Clove	Syzygium aromaticum.
f269	Basil	Ocimum basilicum.
f270	Ginger	Zingiber officinale.
f271	Anise	Pimpinella anisum.
f272	Tarragon	Artemisia dracunculus.
f273	Thyme	Thymus vulgaris.
f274	Marjoram	Origanum majorana.
f275	Lovage	Levisticum officinale.
f276	Fennel, fresh	Foeniculum vulgare.
f277	Dill	Anethum graveolens.
f278	Bay leaf	Laurus nobilis.
f279	Chili pepper	Capsicum frutescens.
f280	Black pepper	Piper nigrum.
f281	Curry (Santa Maria)	NA.
f282	Nutmeg	Myristica fragrans.
f283	Oregano	Origanum vulgare.
f284	Turkey meat	Meleagris gallopavo.
f285	Elk/moose meat	Alces spp.
f286	Mare's milk	Equus caballus (Equus spp.).
f287	Red kidney bean	Phaseolus vulgaris.
f288	Blueberry	Vaccinium myrtillus (Vaccinium spp.).
f289	Date	Phoenix dactylifera.
f291	Cauliflower	Brassica oleracea var. botrytis.
f292	Guava	Psidium guajava.
f293	Papaya	Carica papaya.
f294	Passion fruit, Maracuja	Passiflora edulis (Passiflora spp.).
f295	Carambola	Averrhoa carambola.
f296	Carob	Ceratonia siliqua.
f297	Gum Arabic	Acacia senegal (Acacia spp.).
f298	Tragacanth	Astragalus spp.
f299	Sweet chestnut (chestnut)	Castanea sativa.
f300	Pinto bean	Phaseolus spp.
f301	Persimmon (kaki fruit, sharon)	Diospyros kaki.
f302	Mandarin (tangerine, clementine, satsumas)	Citrus reticulata.
f305	Fenugreek	Trigonella foenum-graecum.
f306	Lime	Citrus aurantifolia.
f307	Hake	Merluccius merluccius.
f308	Sardine (pilchard)	Sardina pilchardus.
f310	Blue vetch	Lathyrus sativus.
f311	Megrim	Lepidorhombus whiffiagonis.
f315	Green bean	Phaseolus vulgaris.
f316	Rape seed	Brassica napus.
f317	Coriander	Coriandrum sativum.
f318	Jack fruit	Artocarpus heterophyllus.
f319	Beetroot	Beta vulgaris.
f320	Crayfish	Astacus astacus.
f321	Horse meat	Equus caballus (Equus spp.).
f322	Red currant	Ribes sylvestre.
f324	Hop (fruit cone)	Humulus lupulus.
f325	Saffron	Colchicum autumnale.
f328	Fig	Ficus carica.
f329	Watermelon	Citrullus lanatus.
f330	Rose hip	Rosa spp.
f331	Saffron	Crocus sativus.
f332	Mint	Mentha piperita.
f333	Linseed	Linum usitatissimum.
f336	Jujube	Ziziphus jujuba.
f336	Wine vinegar	Vitis vinifera (Vitis spp.).
f337	Sole	Solea solea.
f337	English sole	Parophrys vetulus.
f338	Wine, white	Vitis vinifera (Vitis spp.).
f339	Allspice	Pimenta dioica.
f339	Wine, red	Vitis vinifera (Vitis spp.).
f341	Cranberry	Vaccinium oxycoccus, Vaccinium macrocarpon.
f342	Olive (black, fresh)	Olea europaea.
f343	Raspberry	Rubus idaeus.
f344	Sage	Salvia officinalis.
f346	Chives	Allium schoenoprasum.
f347	Quinoa	Chenopodium quinoa.
f348	Litchi	Litchi chinensis.
f349	Chum salmon roe	Oncorhynchus keta.
f358	Artichoke	Cynara scolymus.
f360	Yogurt	NA.
f368	Black bass	Micropterus dolomieu (Micropterus dolomieui).
f374	Karaya gum	Sterculia urens.
f375	Horseradish	Armoracia rusticana.
f377	Maple syrup	NA.
f379	Okra	Abelmoschus esculentus.
f382	Beet, sugar	Beta vulgaris var. altissima.
f401	Loquat	Eriobotrya japonica.
f402	Fig	Ficus carica.
f403	Brewer's yeast	Saccharomyces cerevisiae.
f405	Mint	Mentha spp.
f406	Arugula	Eruca vesicaria.
House Dust
h1	Greer Labs., Inc	NA.
h2	Hollister-Stier Labs	NA.
h6	Japan	NA.
Venoms & Insects
i7	Midge	Chironomus yoshimatsui.
i8	Moth	Bombyx mori, Heterocera spp.
i47	Water flea	Daphnia spp.
i49	Deer fly	Chrysops spp.
i51	Black ant	Camponotus pennsylvanicus.
i54	Flea mix (dog/cat), common flea	Ctenocephalides spp.
i71	Mosquito	Aedes communis, Aedes spp. and Culex spp.
i72	Green nimitti	Cladotanytarsus lewisi.
i73	Blood worm	Chironomus thummi, Chironomusri parius, Chironomus spp.
i75	European hornet	Vespa crabro.
i76	Berlin beetle	Trogoderma angustum.
i77	European paper wasp	Polistes dominulus.
i78	Fly	Musca domestica.
i80	Bumblebee	Bombus pennsylvanicus.
i201	Horse bot fly	Gasterophilus intestinalis.
i202	Grain weevil	Sitophilus granarius.
i203	Mediterranean flour moth	Ephestia kuehniella (Anagasta kuehniella).
i204	Horse fly	Tabanus spp.
i205	Bumblebee	Bombus terrestris.
i208	Api m 1.0101	Apis mellifera.
a45	Api m 1	Apis mellifera.
i209	Ves v 5.0101	Vespula vulgaris.
a670	Ves v 5	Vespula vulgaris.
i210	Pol d 5.0101	Polistes dominulus.
i211	Ves v 1.0101	Vespula vulgaris.
i213	Api m 4	Apis mellifera.
i214	Api m 2	Apis mellifera.
i215	Api m 3	Apis mellifera.
i216	Api m 5	Apis mellifera.
i217	Api m 10	Apis mellifera.
i220	Bla g 1.0101	Blattella germanica.
i221	Bla g 2.0101	Blattella germanica.
i222	Bla g 5.0101	Blattella germanica.
i223	Bla g 7	Blattella germanica.
a46	Api m 2	Apis mellifera.
Miscellaneous
o1	Cotton, crude fibers	Gossypium spp.
o3	Cotton (treated)	Gossypium spp.
o70	Seminal fluid	Homo sapiens.
o71	Staphylococcus aureus	Staphylococcus aureus.
o72	Pichia pastoris crude extract customer specific	Pichia pastoris.
o72	Sperm-sediment	Homo sapiens.
o73	Pichia pastoris crude extr. vector customer specific	Pichia pastoris.
o74	Pichia pastoris with vector customer specific	Pichia pastoris.
o201	Tobacco leaf, tobacco dust	Nicotiana tabacum.
o202	Artemia salina, fish feed	Artemia salina.
o203	Tetramin, fish feed	NA.
o207	Daphnia, fish feed	Daphnia spp.
o211	Mealworm	Tenebrio molitor.
o212	Streptavidin	Streptomyces avidini.
o213	MBP (maltose binding protein)	Escherichia coli.
o214	CCD; MUXF3 from bromelain	Ananas comosus.
o72	Enterotoxin A (Sta a SEA)	Staphylococcus aureus.
o73	Enterotoxin B (Sta a SEB)	Staphylococcus aureus.
Parasites
p1	Ascaris	Ascaris suum.
p2	Echinococcus	Echinococcus granulosus.
p3	Schistosoma	Schistosoma mansoni.
p4	Anisakis (Herring Worm)	Anisakis simplex (Anisakis spp.).
p5	Toxocara canis	Toxocara canis.
p10	Ani s 3.0101	Anisakis simplex (Anisakis spp.).
p11	Ani s 1	Anisakis simplex (Anisakis spp.).
Occupational
k4	Threshing dust	NA.
k5	Flax	NA.
k7	Hay Dust	NA.
k8	Hop (hops)	Humulus lupulus.
k12	Grain mill dust	NA.
k14	Kapok	NA.
k20	Sheep's wool (treated) (wool)	Ovis aries (Ovis spp.).
k21	Sheep's wool (Untreated)	Ovis aries (Ovis spp.).
k23	Straw Dust	NA.
k33	Oak	NA.
k70	Green coffee bean	Coffea spp.
k71	Castor bean	Ricinus communis.
k72	Ispaghula	Plantago psyllium/Plantago ovata.
k73	Silk waste	NA.
k74	Silk	Bombyx mori.
k75	Isocyanate TDI (Toluene diisocyanate)	NA.
k76	Isocyanate MDI (Diphenylmethane diisocyanate)	NA.
k77	Isocyanate HDI (Hexamethylen diisocyanate)	NA.
k78	Ethylene oxide	NA.
k79	Phthalic anhydride	NA.
k80	Formaldehyde/Formalin	NA.
k81	Ficus	Ficus benjamina (Ficus spp.).
k83	Cotton seed	Gossypium hirsutum.
k84	Sunflower seed	Helianthus annuus.
k85	Chloramin T	NA.
k86	Trimellitic anhydride, TMA	NA.
k87	Asp o 21, alpha-amylase	Aspergillus oryzae.
k89	Orris root	Iris florentina.
k99	HSA (Human Serum Albumin) (Hom s HSA)	Homo sapiens.
k201	Car p 1, Papain	Carica papaya.
k202	Ana c 2, Bromelain	Ananas comosus.
k204	Maxatase	Bacillus licheniformis.
k205	Alcalase	Bacillus spp.
k206	Savinase, Protease 1 (Bac l Subtilisin)	Bacillus spp.
k208	Gal d 4, Lysozyme	Gallus domesticus (Gallus gallus domesticus; Gallus spp.).
k209	Hexahydrophtalic anhydrid	NA.
k210	Maleic anhydride	NA.
k211	Methyltetrahydrophtalic anhydrid	NA.
k212	Abachi wood dust	Triplochiton scleroxylon.
k213	Pepsin (Sus s Pepsin)	Sus scrofa (Sus scrofa domesticus; Sus spp.).
k213	TCPA	NA.
k214	Bougainvillea	Bougainvillea spp.
k225	Horse radish peroxidase (Arm r HRP)	Armoracia rusticana.
k226	Ascorbate oxidase (Cuc p ascorbate oxidase)	Cucurbita pepo.
k301	Flour dust	Triticum spp.
k501	Savinase customer specific	Proprietary knowledge of customer.
k502	Lipolase customer specific	Proprietary knowledge of customer.
k503	Termamyl customer specific	Proprietary knowledge of customer.
k504	Clazinase customer specific	Proprietary knowledge of customer.

21 C.F.R. §866.5750

47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800 , Dec. 30, 2019