| 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 (K261027) | Hycor Biomedical | 2026-07-24 |
| 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 (K260591) | Hycor Biomedical | 2026-07-21 |
| 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 (K260280) | Hycor Biomedical | 2026-06-18 |
| 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) (K260059) | Hycor Biomedical | 2026-05-15 |
| 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 (K252775) | Hycor Biomedical | 2026-01-16 |
| 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) (K252493) | Hycor Biomedical | 2025-12-23 |
| 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 (K242531) | Hycor Biomedical | 2025-04-23 |
| 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 (K212181) | Phadia AB | 2022-08-03 |
| Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria (K220162) | Hycor Biomedical | 2022-02-18 |
| Allergen-Specific IgE Assay 12 Allergen Bundle (K193613) | Hitachi Chemical Diagnostics, Inc. | 2021-10-18 |
| NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense (K200825) | Hycor Biomedical | 2020-06-26 |
| ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine (K200279) | Phadia AB | 2020-05-01 |
| Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae (K191510) | Hycor Biomedical | 2019-07-31 |
| 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 (K190315) | Phadia AB | 2019-05-14 |
| AP3600 Automated Instrument (K182793) | Hitachi Chemical Diagnostics, Inc. | 2019-03-19 |
| NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus (K182479) | Hycor Biomedical | 2018-12-04 |
| ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut (K173726) | Phadia AB | 2018-04-16 |
| ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE (K163370) | Phadia AB | 2017-05-05 |
| ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite (K150597) | Phadia AB | 2016-02-29 |
| Phadia Prime (K151029) | Phadia AB | 2016-01-19 |
| ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut (K150854) | Phadia AB | 2015-12-14 |
| IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY (K132801) | Siemens Healthcare Diagnostics, Inc. | 2014-05-28 |
| AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES (K122197) | Phadia US, Inc. | 2013-08-28 |
| IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H (K131738) | Phadia AB | 2013-07-10 |
| IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM (K123275) | Phadia AB | 2013-06-28 |
| AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES (K121156) | Phadia AB | 2013-03-13 |
| IMMUNOCAP ALLERGEN K82 (K121463) | Thermo Fisher Scientific | 2013-01-29 |
| AP 72OS SEMI-AUTOMATED INSTRUMENT (K112910) | Hitachi Chemical Diagnostics, Inc. | 2012-12-20 |
| IMMUNOCAP ALLERGEN COMPONENTS BUNDLE (K113841) | Phadia US, Inc. | 2012-09-13 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K112523) | Siemens Healthcare Diagnostics, Inc. | 2012-01-06 |
| IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS (K111919) | Phadia US, Inc. | 2011-12-22 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K101572) | Siemens Healthcare Diagnostics | 2011-08-01 |
| IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN (K101251) | Phadia AB | 2011-05-27 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (K100910) | Siemens Medical Solutions Diagnostics | 2011-05-11 |
| IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 (K093987) | Siemens Healthcare Diagnostics, Inc. | 2011-03-28 |
| IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 (K100999) | Phadia AB | 2010-12-15 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K093107) | Siemens Healthcare Diagnostics | 2010-09-30 |
| IMMUNOCAP RAPID READER, MODEL 12-3600-10 (K092978) | Phadia US, Inc. | 2010-01-19 |
| IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 (K092050) | Phadia AB | 2009-11-20 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (K091984) | Siemens Medical Solutions Diagnostics | 2009-10-28 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K091289) | Siemens Healthcare Diagnostics | 2009-08-06 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K090257) | Siemens Healthcare Diagnostics | 2009-05-26 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K083853) | Siemens Healthcare Diagnostics | 2009-03-24 |
| IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 (K081830) | Phadia AB | 2009-03-16 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K083314) | Siemens Healthcare Diagnostics | 2009-03-11 |
| HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM (K081217) | Hycor Biomedical, Inc. | 2008-05-22 |
| HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 (K080322) | Hycor Biomedical, Inc. | 2008-03-05 |
| IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 (K071913) | Phadia AB | 2007-08-24 |
| OPTIGEN ALLERGEN SPECIFIC IGE ASSAY (K051677) | Hitachi Chemical Diagnostics, Inc. | 2006-01-23 |
| MODIFICATION TO: UNICAP SPECIFIC IGE (K051218) | Pharmacia Diagnostics AB | 2005-06-09 |
| CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) (K030590) | Hitachi Chemical Diagnostics, Inc. | 2003-03-21 |
| IMMULITE 2000 ALLERGEN-SPECIFIC IGE (K023152) | Diagnostic Products Corp. | 2002-12-17 |
| IMMULITE 2000 SPECIFIC ALLERGENS (K021206) | Diagnostic Products Corp. | 2002-05-30 |
| IMMULITE 2000 MIXED ALLERGEN PANELS (K021208) | Diagnostic Products Corp. | 2002-05-30 |
| MYALLERGYTEST SYSTEM (K020387) | Immunetech Corporation | 2002-04-17 |
| IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) (K013135) | Diagnostic Products Corp. | 2001-10-19 |
| IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) (K013134) | Diagnostic Products Corp. | 2001-10-15 |
| ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 (K000132) | Pharmacia & Upjohn Co. | 2000-02-18 |
| ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F (K993388) | Pharmacia & Upjohn Co. | 1999-12-01 |
| ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 (K991048) | Pharmacia & Upjohn Co. | 1999-05-14 |
| ALASTAT MICROPLATE MIXED ALLERGEN PANELS (K983954) | Diagnostic Products Corp. | 1998-12-17 |
| ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3 (K982343) | Pharmacia & Upjohn Co. | 1998-09-15 |
| ALLERGEN IMMUNOCAP F256,F245,F207,F202 (K974580) | Pharmacia & Upjohn Co. | 1998-02-09 |
| ALLERGAN IMMUNO CAP M4, M8, K70 (K974350) | Pharmacia, Inc. | 1998-02-09 |
| IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE (K973186) | Diagnostic Products Corp. | 1997-09-29 |
| UNICAP PHADIATOP (K972364) | Pharmacia, Inc. | 1997-09-04 |
| UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 (K972068) | Pharmacia, Inc. | 1997-07-03 |
| HYCOR ALLERGEN DISC (K965094) | Hycor Biomedical, Inc. | 1997-05-21 |
| PHARMACIA CAP SYSTEM RAST FEIA (K962976) | Pharmacia & Upjohn Co. | 1996-12-23 |
| IMMULITE LATEX-SPECIFIC IGE (K963245) | Diagnostic Products Corp. | 1996-11-18 |
| SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS (K961889) | Diagnostic Products Corp. | 1996-10-10 |
| UNICAP 100 (K962274) | Pharmacia, Inc. | 1996-09-12 |
| PHARMACIA CAP SYSTEM PHADIATOP FEIA (K941993) | Pharmacia, Inc. | 1996-01-30 |
| SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM (K954566) | Diagnostic Products Corp. | 1995-12-18 |
| ACCESS ALLERGEN DOG EPITHELIM (K953780) | Bio-Rad Laboratories, Inc. | 1995-11-14 |
| QUICKVUE ONE-STEP ALLERGEN SCREEN (K950728) | Quidel Corp. | 1995-10-02 |
| ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN (K953014) | Diagnostic Products Corp. | 1995-08-15 |
| SPECIFIC IGE ULTRA-EIA (K945884) | Hycor Biomedical, Inc. | 1995-06-30 |
| HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY (K945748) | Hycor Biomedical, Inc. | 1995-06-07 |
| ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR (K950629) | Bio-Rad Laboratories, Inc. | 1995-05-23 |
| LATEX (K82) (K931746) | Diagnostic Products Corp. | 1995-03-21 |
| HY-TEC AUTOMATED EIA SYSTEM (K941278) | Hycor Biomedical, Inc. | 1995-03-13 |
| HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT (K943768) | Diagnostic Products Corp. | 1995-03-06 |
| SPECIFIC IGE EIA-ULTRA ASSAY (K941057) | Hycor Biomedical, Inc. | 1995-01-20 |
| IMMULITE ALATOP ALLERGY SCREEN (K941564) | Diagnostic Products Corp. | 1994-12-19 |
| ALATOP(R) MICROPLATE ALLERGY SCREEN (K935488) | Diagnostic Products Corp. | 1994-03-22 |
| ACCESS SPECIFIC IGE ASSAY (K935876) | Bio-Rad Laboratories, Inc. | 1994-03-11 |
| MAST CLA ALLERGY SYSTEM (K934524) | Mast Immunosystems | 1994-03-07 |
| MAST CLA ALLERGY SYSTEM (K926420) | Mast Immunosystems | 1994-03-07 |
| VENTREX ALLERGEN DISC (K925044) | Ventrex, Inc. | 1993-05-14 |
| CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY (K923420) | Ciba Corning Diagnostics Corp. | 1993-02-23 |
| SPECIFIC IGE EIA-TURBO ASSAY (K925425) | Hycor Biomedical, Inc. | 1993-01-14 |
| VENTREX ALLERGEN DISC (K924044) | Hycor Biomedical, Inc. | 1992-12-01 |
| VENTREX ALLERGEN DISC (K924119) | Ventrex, Inc. | 1992-11-30 |
| VENTREX ALLERGEN DISC (K924209) | Hycor Biomedical, Inc. | 1992-11-30 |
| BASELINE CALIBRATION VERIFICATION CONTROLS (K923284) | Hycor Biomedical, Inc. | 1992-09-28 |
| 866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS (K914685) | In Vitro Technologies, Inc. | 1992-09-14 |
| MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM (K914959) | Ciba Corning Diagnostics Corp. | 1992-08-20 |
| WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC (K921574) | Hycor Biomedical, Inc. | 1992-08-03 |
| VENTREX ALLERGEN DISC (K922538) | Hycor Biomedical, Inc. | 1992-07-27 |