System, Test, Radioallergosorbent (Rast) Immunological

DHB 2026-07-24

NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut

Applicant Hycor Biomedical

K number K261027

DHB 2026-07-21

NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut

Applicant Hycor Biomedical

K number K260591

DHB 2026-06-18

NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg

Applicant Hycor Biomedical

K number K260280

DHB 2026-05-15

NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)

Applicant Hycor Biomedical

K number K260059

DHB 2026-01-16

NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg

Applicant Hycor Biomedical

K number K252775

DHB 2025-12-23

NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)

Applicant Hycor Biomedical

K number K252493

DHB 2025-04-23

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz

Applicant Hycor Biomedical

K number K242531

DHB 2022-08-03

ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed

Applicant Phadia AB

K number K212181

DHB 2022-02-18

Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria

Applicant Hycor Biomedical

K number K220162

DHB 2021-10-18

Allergen-Specific IgE Assay 12 Allergen Bundle

K number K193613

DHB 2020-06-26

NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense

Applicant Hycor Biomedical

K number K200825

DHB 2020-05-01

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine

Applicant Phadia AB

K number K200279

DHB 2019-07-31

Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae

Applicant Hycor Biomedical

K number K191510

DHB 2019-05-14

ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat

Applicant Phadia AB

K number K190315

DHB 2019-03-19

AP3600 Automated Instrument

K number K182793

DHB 2018-12-04

NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus

Applicant Hycor Biomedical

K number K182479

DHB 2018-04-16

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut

Applicant Phadia AB

K number K173726

DHB 2017-05-05

ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE

Applicant Phadia AB

K number K163370

DHB 2016-02-29

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite

Applicant Phadia AB

K number K150597

DHB 2016-01-19

Phadia Prime

Applicant Phadia AB

K number K151029

DHB 2013-08-28

AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES

Applicant Phadia US, Inc.

K number K122197

DHB 2013-07-10

IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H

Applicant Phadia AB

K number K131738

DHB 2013-06-28

IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM

Applicant Phadia AB

K number K123275

DHB 2013-03-13

AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES

Applicant Phadia AB

K number K121156

DHB 2013-01-29

IMMUNOCAP ALLERGEN K82

Applicant Thermo Fisher Scientific

K number K121463

DHB 2012-12-20

AP 72OS SEMI-AUTOMATED INSTRUMENT

K number K112910

DHB 2012-09-13

IMMUNOCAP ALLERGEN COMPONENTS BUNDLE

Applicant Phadia US, Inc.

K number K113841

DHB 2012-01-06

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

Applicant Siemens Healthcare Diagnostics, Inc.

K number K112523

DHB 2011-12-22

IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS

Applicant Phadia US, Inc.

K number K111919

DHB 2011-08-01

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

K number K101572

DHB 2011-05-27

IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN

Applicant Phadia AB

K number K101251

DHB 2011-05-11

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6

Applicant Siemens Medical Solutions Diagnostics

K number K100910

DHB 2011-03-28

IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6

Applicant Siemens Healthcare Diagnostics, Inc.

K number K093987

DHB 2010-12-15

IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01

Applicant Phadia AB

K number K100999

DHB 2010-09-30

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

K number K093107

DHB 2010-01-19

IMMUNOCAP RAPID READER, MODEL 12-3600-10

Applicant Phadia US, Inc.

K number K092978

DHB 2009-11-20

IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01

Applicant Phadia AB

K number K092050

DHB 2009-10-28

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6

Applicant Siemens Medical Solutions Diagnostics

K number K091984

DHB 2009-08-06

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

K number K091289

DHB 2009-05-26

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

K number K090257

DHB 2009-03-24

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

K number K083853

DHB 2009-03-16

IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1

Applicant Phadia AB

K number K081830

DHB 2009-03-11

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

K number K083314

DHB 2008-05-22

HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM

Applicant Hycor Biomedical, Inc.

K number K081217

DHB 2008-03-05

HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200

Applicant Hycor Biomedical, Inc.

K number K080322

DHB 2007-08-24

IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01

Applicant Phadia AB

K number K071913

DHB 2006-01-23

OPTIGEN ALLERGEN SPECIFIC IGE ASSAY

K number K051677

DHB 2005-06-09

MODIFICATION TO: UNICAP SPECIFIC IGE

Applicant Pharmacia Diagnostics AB

K number K051218

DHB 2003-03-21

CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)

K number K030590

DHB 2002-12-17

IMMULITE 2000 ALLERGEN-SPECIFIC IGE

K number K023152

DHB 2002-05-30

IMMULITE 2000 MIXED ALLERGEN PANELS

K number K021208

DHB 2002-05-30

IMMULITE 2000 SPECIFIC ALLERGENS

K number K021206

DHB 2002-04-17

MYALLERGYTEST SYSTEM

Applicant Immunetech Corporation

K number K020387

DHB 2001-10-19

IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)

K number K013135

DHB 2001-10-15

IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)

K number K013134

DHB 2000-02-18

ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8

Applicant Pharmacia & Upjohn Co.

K number K000132

DHB 1999-12-01

ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F

Applicant Pharmacia & Upjohn Co.

K number K993388

DHB 1999-05-14

ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2

Applicant Pharmacia & Upjohn Co.

K number K991048

DHB 1998-12-17

ALASTAT MICROPLATE MIXED ALLERGEN PANELS

K number K983954

DHB 1998-09-15

ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3

Applicant Pharmacia & Upjohn Co.

K number K982343

DHB 1998-02-09

ALLERGEN IMMUNOCAP F256,F245,F207,F202

Applicant Pharmacia & Upjohn Co.

K number K974580

DHB 1998-02-09

ALLERGAN IMMUNO CAP M4, M8, K70

Applicant Pharmacia, Inc.

K number K974350

DHB 1997-09-29

IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE

K number K973186

DHB 1997-09-04

UNICAP PHADIATOP

Applicant Pharmacia, Inc.

K number K972364

DHB 1997-07-03

UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82

Applicant Pharmacia, Inc.

K number K972068

DHB 1997-05-21

HYCOR ALLERGEN DISC

Applicant Hycor Biomedical, Inc.

K number K965094

DHB 1996-12-23

PHARMACIA CAP SYSTEM RAST FEIA

Applicant Pharmacia & Upjohn Co.

K number K962976

DHB 1996-11-18

IMMULITE LATEX-SPECIFIC IGE

K number K963245

DHB 1996-10-10

SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS

K number K961889

DHB 1996-09-12

UNICAP 100

Applicant Pharmacia, Inc.

K number K962274

DHB 1996-01-30

PHARMACIA CAP SYSTEM PHADIATOP FEIA

Applicant Pharmacia, Inc.

K number K941993

DHB 1995-12-18

SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM

K number K954566

DHB 1995-11-14

ACCESS ALLERGEN DOG EPITHELIM

Applicant Bio-Rad Laboratories, Inc.

K number K953780

DHB 1995-10-02

QUICKVUE ONE-STEP ALLERGEN SCREEN

Applicant Quidel Corp.

K number K950728

DHB 1995-08-15

ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN

K number K953014

DHB 1995-06-30

SPECIFIC IGE ULTRA-EIA

Applicant Hycor Biomedical, Inc.

K number K945884

DHB 1995-06-07

HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY

Applicant Hycor Biomedical, Inc.

K number K945748

DHB 1995-05-23

ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR

Applicant Bio-Rad Laboratories, Inc.

K number K950629

DHB 1995-03-21

LATEX (K82)

K number K931746

DHB 1995-03-13

HY-TEC AUTOMATED EIA SYSTEM

Applicant Hycor Biomedical, Inc.

K number K941278

DHB 1995-03-06

HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT

K number K943768

DHB 1995-01-20

SPECIFIC IGE EIA-ULTRA ASSAY

Applicant Hycor Biomedical, Inc.

K number K941057

DHB 1994-12-19

IMMULITE ALATOP ALLERGY SCREEN

K number K941564

DHB 1994-03-22

ALATOP(R) MICROPLATE ALLERGY SCREEN

K number K935488

DHB 1994-03-11

ACCESS SPECIFIC IGE ASSAY

Applicant Bio-Rad Laboratories, Inc.

K number K935876

DHB 1994-03-07

MAST CLA ALLERGY SYSTEM

Applicant Mast Immunosystems

K number K934524

DHB 1994-03-07

MAST CLA ALLERGY SYSTEM

Applicant Mast Immunosystems

K number K926420

DHB 1993-05-14

VENTREX ALLERGEN DISC

Applicant Ventrex, Inc.

K number K925044

DHB 1993-02-23

CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K923420

DHB 1993-01-14

SPECIFIC IGE EIA-TURBO ASSAY

Applicant Hycor Biomedical, Inc.

K number K925425

DHB 1992-12-01

VENTREX ALLERGEN DISC

Applicant Hycor Biomedical, Inc.

K number K924044

DHB 1992-11-30

VENTREX ALLERGEN DISC

Applicant Hycor Biomedical, Inc.

K number K924209

DHB 1992-11-30

VENTREX ALLERGEN DISC

Applicant Ventrex, Inc.

K number K924119

DHB 1992-09-28

BASELINE CALIBRATION VERIFICATION CONTROLS

Applicant Hycor Biomedical, Inc.

K number K923284

DHB 1992-09-14

866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS

Applicant In Vitro Technologies, Inc.

K number K914685

DHB 1992-08-20

MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM

Applicant Ciba Corning Diagnostics Corp.

K number K914959

DHB 1992-08-03

WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC

Applicant Hycor Biomedical, Inc.

K number K921574

DHB 1992-07-27

VENTREX ALLERGEN DISC

Applicant Hycor Biomedical, Inc.

K number K922538

DHB 1992-03-13

SPECIFIC IGE EIA-TURBO ASSAY

Applicant Ventrex Laboratories, Inc.

K number K914554