System, Test, Radioallergosorbent (Rast) Immunological
FDA product code DHB · Class II (moderate risk) · 21 CFR 866.5750 · Immunology
269510(k) clearances
0PMA approvals
27recalls
Manufacturers
- Pharmacia, Inc. 39
- Diagnostic Products Corp. 26
- Incstar Corp. 25
- Hycor Biomedical, Inc. 24
- Ventrex Laboratories, Inc. 18
- Phadia AB 16
- Immuno Nuclear Corp. 14
- 3M Company 13
- Mast Immunosystems 10
- Quidel Corp. 9
- Siemens Healthcare Diagnostics, Inc. 9
- Ciba Corning Diagnostics Corp. 7
- In Vitro Technologies, Inc. 7
- Pharmacia & Upjohn Co. 6
- Hitachi Chemical Diagnostics, Inc. 5
- Kallestad Laboratories, Inc. 5
- Phadia US, Inc. 4
- Dexall Biomedical Labs, Inc. 3
- Bio-Rad Laboratories, Inc. 3
- Diagnostic Reagent Tech. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)DHB · Traditional | Siemens Healthcare Diagnostics Products, Ltd. | 09/04/2026SE |
| K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent…DHB · Traditional | Hycor Biomedical | 07/24/2026SE |
| K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture…DHB · Traditional | Hycor Biomedical | 07/21/2026SE |
| K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture…DHB · Traditional | Hycor Biomedical | 06/18/2026SE |
| K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa)…DHB · Traditional | Hycor Biomedical | 05/15/2026SE |
| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture…DHB · Traditional | Hycor Biomedical | 01/16/2026SE |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent…DHB · Traditional | Hycor Biomedical | 12/23/2025SE |
| K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum…DHB · Traditional | Hycor Biomedical | 04/23/2025SE |
| K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen…DHB · Traditional | Phadia AB | 08/03/2022SE |
| K220162 | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, AlternariaDHB · Traditional | Hycor Biomedical | 02/18/2022SE |
| K193613 | Allergen-Specific IgE Assay 12 Allergen BundleDHB · Traditional | Hitachi Chemical Diagnostics, Inc. | 10/18/2021SE |
| K200825 | NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS…DHB · Traditional | Hycor Biomedical | 06/26/2020SE |
| K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovineDHB · Traditional | Phadia AB | 05/01/2020SE |
| K191510 | Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002…DHB · Traditional | Hycor Biomedical | 07/31/2019SE |
| K190315 | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230…DHB · Traditional | Phadia AB | 05/14/2019SE |
| K182793 | AP3600 Automated InstrumentDHB · Traditional | Hitachi Chemical Diagnostics, Inc. | 03/19/2019SE |
| K182479 | NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001…DHB · Traditional | Hycor Biomedical | 12/04/2018SE |
| K173726 | ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, PeanutDHB · Traditional | Phadia AB | 04/16/2018SE |
| K163370 | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgEDHB · Traditional | Phadia AB | 05/05/2017SE |
| K150597 | ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust miteDHB · Traditional | Phadia AB | 02/29/2016SE |
| K151029 | Phadia PrimeDHB · Special | Phadia AB | 01/19/2016SE |
| K150854 | ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440…DHB · Traditional | Phadia AB | 12/14/2015SE |
| K132801 | Immulite 2000 Systems 3GALLERGY Specific Ige AssayDHB · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/28/2014SE |
| K122197 | Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige…DHB · Traditional | Phadia US, Inc. | 08/28/2013SE |
| K131738 | Immunocap Specific Ige Control L, Immunocap Specific Ige Control M and Immunocap…DHB · Special | Phadia AB | 07/10/2013SE |
| K123275 | IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4…DHB · Traditional | Phadia AB | 06/28/2013SE |
| K121156 | Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige…DHB · Traditional | Phadia AB | 03/13/2013SE |
| K121463 | Immunocap Allergen K82DHB · Traditional | Thermo Fisher Scientific | 01/29/2013SE |
| K112910 | Ap 72OS Semi-Automated InstrumentDHB · Traditional | Hitachi Chemical Diagnostics, Inc. | 12/20/2012SE |
| K113841 | Immunocap Allergen Components BundleDHB · Traditional | Phadia US, Inc. | 09/13/2012SE |
| K112523 | Immulite 2000 3GALLERGY Specific Ige Assay KitDHB · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/06/2012SE |
| K111919 | Immunocap Specific Ige Allergen Bundle, 12 Allergen ComponentsDHB · Traditional | Phadia US, Inc. | 12/22/2011SE |
| K101572 | Immulite 2000 3GALLERGY Specific Ige Assay KitDHB · Traditional | Siemens Healthcare Diagnostics | 08/01/2011SE |
| K101251 | Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunocap…DHB · Traditional | Phadia AB | 05/27/2011SE |
| K100910 | Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6DHB · Traditional | Siemens Medical Solutions Diagnostics | 05/11/2011SE |
| K093987 | Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6DHB · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/28/2011SE |
| K100999 | Immunocap Allergen F20, Almond Model: 14-4179-01DHB · Traditional | Phadia AB | 12/15/2010SE |
| K093107 | Immulite 2000 3GALLERGY Specific Ige Assay KitDHB · Traditional | Siemens Healthcare Diagnostics | 09/30/2010SE |
| K092978 | Immunocap Rapid Reader, Model 12-3600-10DHB · Traditional | Phadia US, Inc. | 01/19/2010SE |
| K092050 | Immunocap Allergen D201, House Dust Mite, Model 4-4896-01DHB · Traditional | Phadia AB | 11/20/2009SE |
| K091984 | Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6DHB · Traditional | Siemens Medical Solutions Diagnostics | 10/28/2009SE |
| K091289 | Immulite 2000 3GALLERGY Specific Ige Assay KitDHB · Traditional | Siemens Healthcare Diagnostics | 08/06/2009SE |
| K090257 | Immulite 2000 3GALLERGY Specific Ige Assay KitDHB · Traditional | Siemens Healthcare Diagnostics | 05/26/2009SE |
| K083853 | Immulite 2000 3GALLERGY Specific Ige Assay KitDHB · Traditional | Siemens Healthcare Diagnostics | 03/24/2009SE |
| K081830 | Immunocap Rapid Inhalant Profile , Immunocap Rapid Reader, Immunocap Rapid Reader Check…DHB · Traditional | Phadia AB | 03/16/2009SE |
| K083314 | Immulite 2000 3GALLERGY Specific Ige Assay KitDHB · Traditional | Siemens Healthcare Diagnostics | 03/11/2009SE |
| K081217 | Hy-Tec Specific and Total Ige Eia SystemDHB · Special | Hycor Biomedical, Inc. | 05/22/2008SE |
| K080322 | Hy*Tec Extended Specific Ige Eia, MCS Assay Using Tecan Freedom Evo RSP 200DHB · Special | Hycor Biomedical, Inc. | 03/05/2008SE |
| K071913 | Immunocap Allergen F338, Scallop with Model(S): 14-4895-01DHB · Traditional | Phadia AB | 08/24/2007SE |
| K051677 | Optigen Allergen Specific Ige AssayDHB · Traditional | Hitachi Chemical Diagnostics, Inc. | 01/23/2006SE |
| K051218 | Modification to: Unicap Specific IgeDHB · Special | Pharmacia Diagnostics AB | 06/09/2005SE |
| K030590 | Cla Allergen-Specific Ige Assay-Latex Allergen (K82)DHB · Special | Hitachi Chemical Diagnostics, Inc. | 03/21/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | Diagnostic Products Corp. | 12/17/2002SE |
| K021208 | Immulite 2000 Mixed Allergen PanelsDHB · Traditional | Diagnostic Products Corp. | 05/30/2002SE |
| K021206 | Immulite 2000 Specific AllergensDHB · Traditional | Diagnostic Products Corp. | 05/30/2002SE |
| K020387 | Myallergytest SystemDHB · Traditional | Immunetech Corporation | 04/17/2002SE |
| K013135 | Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels, Model L2KUN6 (600 Tests)DHB · Special | Diagnostic Products Corp. | 10/19/2001SE |
| K013134 | Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600 Tests)DHB · Special | Diagnostic Products Corp. | 10/15/2001SE |
| K000132 | Allergen Immunocap, Models C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73…DHB · Traditional | Pharmacia & Upjohn Co. | 02/18/2000SE |
| K993388 | Allergen Immundocap MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59…DHB · Traditional | Pharmacia & Upjohn Co. | 12/01/1999SE |
| K991048 | Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216…DHB · Traditional | Pharmacia & Upjohn Co. | 05/14/1999SE |
| K983954 | Alastat Microplate Mixed Allergen PanelsDHB · Traditional | Diagnostic Products Corp. | 12/17/1998SE |
| K982343 | Allergen Immunocap Models D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92…DHB · Traditional | Pharmacia & Upjohn Co. | 09/15/1998SE |
| K974580 | Allergen Immunocap F256,F245,F207,F202DHB · Traditional | Pharmacia & Upjohn Co. | 02/09/1998SE |
| K974350 | Allergan Immuno Cap M4, M8, K70DHB · Traditional | Pharmacia, Inc. | 02/09/1998SE |
| K973186 | Immulite Cat-Specific Ige, Immulite Dog-Specific Ige,Immulite Mite-Specific IgeDHB · Traditional | Diagnostic Products Corp. | 09/29/1997SE |
| K972364 | Unicap PhadiatopDHB · Traditional | Pharmacia, Inc. | 09/04/1997SE |
| K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82DHB · Traditional | Pharmacia, Inc. | 07/03/1997SE |
| K965094 | Hycor Allergen DiscDHB · Traditional | Hycor Biomedical, Inc. | 05/21/1997SE |
| K962976 | Pharmacia Cap System Rast FeiaDHB · Traditional | Pharmacia & Upjohn Co. | 12/23/1996SE |
| K963245 | Immulite Latex-Specific IgeDHB · Traditional | Diagnostic Products Corp. | 11/18/1996SE |
| K961889 | Specific Allergen Modules and Mixed Allergen Panels for Alastat Microplate and Alastat…DHB · Traditional | Diagnostic Products Corp. | 10/10/1996SE |
| K962274 | Unicap 100DHB · Traditional | Pharmacia, Inc. | 09/12/1996SE |
| K941993 | Pharmacia Cap System Phadiatop FeiaDHB · Traditional | Pharmacia, Inc. | 01/30/1996SE |
| K954566 | Specific Allergen Modules for the Alastat Microplate Allergen-Specific Ige SystemDHB · Traditional | Diagnostic Products Corp. | 12/18/1995SE |
| K953780 | Access Allergen Dog EpithelimDHB · Traditional | Bio-Rad Laboratories, Inc. | 11/14/1995SE |
| K950728 | Quickvue One-Step Allergen ScreenDHB · Traditional | Quidel Corp. | 10/02/1995SE |
| K953014 | Alastat Microplate Latex-Specific Ige AllergenDHB · Traditional | Diagnostic Products Corp. | 08/15/1995SE |
| K945884 | Specific Ige Ultra-EiaDHB · Traditional | Hycor Biomedical, Inc. | 06/30/1995SE |
| K945748 | Hycor Specific Ige Enzyme ImmunoassayDHB · Traditional | Hycor Biomedical, Inc. | 06/07/1995SE |
| K950629 | Access Allergens - Fematophagoides Farinae, Cat Dander, Timothy Grass, and Alternaria…DHB · Traditional | Bio-Rad Laboratories, Inc. | 05/23/1995SE |
| K931746 | Latex (K82)DHB · Traditional | Diagnostic Products Corp. | 03/21/1995SE |
| K941278 | Hy-Tec Automated Eia SystemDHB · Traditional | Hycor Biomedical, Inc. | 03/13/1995SE |
| K943768 | Honey Bee, Yellow Jacket, Paper Wasp, Imported Fire AntDHB · Traditional | Diagnostic Products Corp. | 03/06/1995SE |
| K941057 | Specific Ige Eia-Ultra AssayDHB · Traditional | Hycor Biomedical, Inc. | 01/20/1995SE |
| K941564 | Immulite Alatop Allergy ScreenDHB · Traditional | Diagnostic Products Corp. | 12/19/1994SE |
| K935488 | Alatop(R) Microplate Allergy ScreenDHB · Traditional | Diagnostic Products Corp. | 03/22/1994SE |
| K935876 | Access Specific Ige AssayDHB · Traditional | Bio-Rad Laboratories, Inc. | 03/11/1994SE |
| K934524 | Mast Cla Allergy SystemDHB · Traditional | Mast Immunosystems | 03/07/1994SE |
| K926420 | Mast Cla Allergy SystemDHB · Traditional | Mast Immunosystems | 03/07/1994SE |
| K925044 | Ventrex Allergen DiscDHB · Traditional | Ventrex, Inc. | 05/14/1993SE |
| K923420 | Ciba Corning Magic Lite SQ Specific Ige AssayDHB · Traditional | Ciba Corning Diagnostics Corp. | 02/23/1993SE |
| K925425 | Specific Ige Eia-Turbo AssayDHB · Traditional | Hycor Biomedical, Inc. | 01/14/1993SE |
| K924044 | Ventrex Allergen DiscDHB · Traditional | Hycor Biomedical, Inc. | 12/01/1992SE |
| K924209 | Ventrex Allergen DiscDHB · Traditional | Hycor Biomedical, Inc. | 11/30/1992SE |
| K924119 | Ventrex Allergen DiscDHB · Traditional | Ventrex, Inc. | 11/30/1992SE |
| K923284 | Baseline Calibration Verification ControlsDHB · Traditional | Hycor Biomedical, Inc. | 09/28/1992SE |
| K914685 | 866.5750 Radioallergosorbent Immunlogical Test SysDHB · Traditional | In Vitro Technologies, Inc. | 09/14/1992SE |
| K914959 | Magic Lite SQ Specific Ige Immunoassay SystemDHB · Traditional | Ciba Corning Diagnostics Corp. | 08/20/1992SE |
| K921574 | White Ash - Fraxinus Americana (T15) Allergen DiscDHB · Traditional | Hycor Biomedical, Inc. | 08/03/1992SE |
| K922538 | Ventrex Allergen DiscDHB · Traditional | Hycor Biomedical, Inc. | 07/27/1992SE |
| K914554 | Specific Ige Eia-Turbo AssayDHB · Traditional | Ventrex Laboratories, Inc. | 03/13/1992SE |
| K913833 | Ventrex Allergen DiscDHB · Traditional | Ventrex Laboratories, Inc. | 02/21/1992SE |
| K914850 | Chemiluminescent System Allergan Specific IgeDHB · Traditional | Mast Immunosystems | 12/09/1991SE |
| K913150 | Abbott Matrix Aero Plus SystemDHB · Traditional | Abbott Laboratories | 11/29/1991SE |
| K913212 | 3M Ige Single Point Fast TestDHB · Traditional | Whittaker Bioproducts, Inc. | 11/22/1991SE |
| K912294 | Allergy Information ManagerDHB · Traditional | Diagnostic Products Corp. | 11/22/1991SE |
| K913892 | Fasttech System IIDHB · Traditional | 3M Diagnostic Systems, Inc. | 10/02/1991SE |
| K911903 | Allergans Pharmacia Cap Sys.Rast Ria/FeiaDHB · Traditional | Pharmacia, Inc. | 08/12/1991SE |
| K912582 | Magic Lite SQ Specific Ige Immunoassay SystemDHB · Traditional | Ciba Corning Diagnostics Corp. | 07/31/1991SE |
| K894227 | Allergen Modules for Alastat TMDHB · Traditional | Diagnostic Products Corp. | 04/17/1991SE |
| K910292 | Mast Cla Allergy SystemDHB · Traditional | Mast Immunosystems | 04/05/1991SE |
| K905054 | Ciba Corning Model 980 Magic Lite Allergy ManagerDHB · Traditional | Ciba Corning Diagnostics Corp. | 03/22/1991SE |
| K910517 | Cap System Rast Asm/Ria and Asm/FeiaDHB · Traditional | Pharmacia, Inc. | 03/05/1991SE |
| K905636 | Ventrex Coated Tube Ige Enzyme ImmunoassayDHB · Traditional | Ventrex Laboratories, Inc. | 02/07/1991SE |
| K910075 | Specific Allergen Modules for Alastat Allergen IgeDHB · Traditional | Diagnostic Products Corp. | 01/30/1991SE |
| K905162 | Quidel Total Ige Positive Control SerumDHB · Traditional | Quidel Corp. | 01/14/1991SE |
| K905176 | Positive Control Pad Allergen/Food Allergen ScreenDHB · Traditional | Quidel Corp. | 12/13/1990SE |
| K904330 | Turbo-Rast Specific Ige AssayDHB · Traditional | Ventrex Laboratories, Inc. | 12/07/1990SE |
| K904661 | Ivt Rast TracerDHB · Traditional | In Vitro Technologies, Inc. | 11/29/1990SE |
| K903637 | Alrgn SetDHB · Traditional | Ciba Corning Diagnostics Corp. | 11/21/1990SE |
| K903742 | Add Mix Allergen Panel Mod Alastat(R) Allergen IgeDHB · Traditional | Diagnostic Products Corp. | 10/15/1990SE |
| K902576 | Alastat Allergen-Spec Ige Control DC1A/2A/6A/NGCADHB · Traditional | Diagnostic Products Corp. | 09/04/1990SE |
| K894190 | Pharmacia Cap System Rast Ria & Rast FeiaDHB · Traditional | Pharmacia, Inc. | 01/22/1990SE |
| K897145 | 3M Multi-Allergen Ige Fastscreen S7, (G3,4,5,6,8)DHB · Traditional | 3M Company | 01/10/1990SE |
| K896902 | Enzymun Test R IgeDHB · Traditional | Boehringer Mannheim Corp. | 01/10/1990SE |
| K896852 | Ventrex Coated Tube Ige Enzyme ImmunoassayDHB · Traditional | Ventrex Laboratories, Inc. | 12/18/1989SE |
| K896694 | Ventrezyme Vast Specific Ige AssayDHB · Traditional | Ventrex Laboratories, Inc. | 12/08/1989SE |
| K896592 | Ciba Corning Magic Lite SQ Specific Ige AssayDHB · Traditional | Ciba Corning Diagnostics Corp. | 12/04/1989SE |
| K894253 | Quidel Food Allergen ScreenDHB · Traditional | Quidel Corp. | 07/28/1989SE |
| K893132 | Phadebas Rast(R)/Phadezym(R) Rast Allergen DiscDHB · Traditional | Pharmacia, Inc. | 06/02/1989SE |
| K891135 | Phadiatop Paediatric Ria and EiaDHB · Traditional | Pharmacia, Inc. | 05/09/1989SE |
| K892409 | Quidel Food Allergen Screen - Barley AllergenDHB · Traditional | Quidel Corp. | 05/04/1989SE |
| K884501 | Quidel Food Allergy ScreenDHB · Traditional | Quidel Corp. | 02/17/1989SE |
| K885269 | Addit. Allergens to Include Foods for Allerg*EnsDHB · Traditional | Dexall Biomedical Labs, Inc. | 02/07/1989SE |
| K884883 | 28 Additional Allergen Modules for Alastat(Tm)DHB · Traditional | Diagnostic Products Corp. | 01/23/1989SE |
| K884923 | Mixed Allergen Panel Modules for Alastat(Tm)DHB · Traditional | Diagnostic Products Corp. | 01/11/1989SE |
| K885065 | Ige Fastscreen S6 (F1, F2, F4, F13, F14)DHB · Traditional | 3M Company | 01/04/1989SE |
| K883537 | QM300 Control EDHB · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 11/04/1988SE |
| K884185 | Ciba Corning Magic Lite Total Ige ImmunoassayDHB · Traditional | Ciba Corning Diagnostics Corp. | 10/27/1988SE |
| K883371 | Multi-Allergen Ige Fastscreen V (T1,T3,T5,T7,T10)DHB · Traditional | 3M Company | 10/27/1988SE |
| K883666 | Quidel Allergy ScreenDHB · Traditional | Quidel Corp. | 10/18/1988SE |
| K883616 | Specific Allergen Modules for Alastat(Tm)DHB · Traditional | Diagnostic Products Corp. | 09/22/1988SE |
| K883273 | Dhbti-Allergen Ige Fastscreen IV (G1,G5,G12,G13)DHB · Traditional | 3M Company | 09/07/1988SE |
| K881899 | Specific Allergen Modules for Alastat(Tm) Ige Sys.DHB · Traditional | Diagnostic Products Corp. | 08/10/1988SE |
| K875110 | House Dust; Hollister-Stier (H/S) Allergen DiscDHB · Traditional | Incstar Corp. | 06/14/1988SE |
| K880899 | Pharmacia Igg Rast Ria/Pharmacia Igg Rast EiaDHB · Traditional | Pharmacia, Inc. | 05/16/1988SE |
| K880221 | Incstar's Pigweed Allergen DiscDHB · Traditional | Incstar Corp. | 05/11/1988SE |
| K880168 | Incstar's Birch Allergen DiscDHB · Traditional | Incstar Corp. | 05/11/1988SE |
| K874883 | Walnut Allergen DiscDHB · Traditional | Incstar Corp. | 05/11/1988SE |
| K874540 | Marsh Elder Allergen DiscDHB · Traditional | Incstar Corp. | 05/11/1988SE |
| K880567 | White Ash Allergen DiscDHB · Traditional | Incstar Corp. | 04/21/1988SE |
| K880415 | Mesquite Allergen DiscDHB · Traditional | Incstar Corp. | 04/21/1988SE |
| K880187 | Incstar's Dandelion Allergen DiscDHB · Traditional | Incstar Corp. | 04/21/1988SE |
| K880160 | Dpc's Allergen-Specific Ige SystemDHB · Traditional | Diagnostic Products Corp. | 04/21/1988SE |
| K875244 | Alleia (TM) Allergen Specific Ige SystemDHB · Traditional | Diagnostic Products Corp. | 04/21/1988SE |
| K875163 | Goldenrod Allergen DiscDHB · Traditional | Incstar Corp. | 04/21/1988SE |
| K875329 | Ivt Central Allergy ScreenDHB · Traditional | In Vitro Technologies, Inc. | 04/07/1988SE |
| K874717 | Quidel Allergy ScreenDHB · Traditional | Quidel Corp. | 04/06/1988SE |
| K880547 | Ventrezyme Vast Immuno-Peroxidase AssayDHB · Traditional | Ventrex Laboratories, Inc. | 03/25/1988SE |
| K875328 | Ivt Western Allergy ScreenDHB · Traditional | In Vitro Technologies, Inc. | 03/23/1988SE |
| K875168 | Quidel Total Ige TestDHB · Traditional | Quidel Corp. | 03/18/1988SE |
| K880003 | Additional Allergens for Ige Fast-Plus TestDHB · Traditional | Em Diagnostic Systems, Inc. | 03/11/1988SE |
| K880001 | Multi-Allergen Ige Fast Screen III D1,E1,G6,M2,T3DHB · Traditional | 3M Company | 02/25/1988SE |
| K875125 | Progene(Tm) Ige TestDHB · Traditional | Progene Corp. | 02/25/1988SE |
| K880002 | Multi-Allergen Ige Fast Screen (Molds)DHB · Traditional | 3M Company | 02/17/1988SE |
| K875274 | Total Ige Immuno Response Test (Irt(R))DHB · Traditional | Incstar Corp. | 02/17/1988SE |
| K874802 | Flipscreen QatDHB · Traditional | Alerchek, Inc. | 02/17/1988SE |
| K875066 | Additional Allergens for Allerg*Ens Eia KitDHB · Traditional | Dexall Biomedical Labs, Inc. | 01/29/1988SE |
| K874169 | Ivt Northeast Allergy ScreenDHB · Traditional | In Vitro Technologies, Inc. | 01/11/1988SE |
| K874168 | Ivt Southeast Allergy ScreenDHB · Traditional | In Vitro Technologies, Inc. | 01/11/1988SE |
| K874446 | Multi-Allergen Ige Fast Screen (Environmental)DHB · Traditional | 3M Company | 12/30/1987SE |
| K874281 | Medix Biotech Ige Visual Screening Test KitDHB · Traditional | Medix Biotech, Inc. | 12/18/1987SE |
| K874440 | Live Oak Allergen DiscDHB · Traditional | Incstar Corp. | 11/25/1987SE |
| K874150 | Johnson Grass Allergen DiscDHB · Traditional | Incstar Corp. | 11/04/1987SE |
| K874149 | False Ragweed Allergen DiscDHB · Traditional | Incstar Corp. | 11/04/1987SE |
| K873998 | Total Ige Fast (TM) Test PackageDHB · Traditional | 3M Company | 11/04/1987SE |
| K873969 | Giant Ragweed Allergen DiscDHB · Traditional | Incstar Corp. | 11/04/1987SE |
| K873814 | Ige Immuno Response Test (Irt) Comp. for Mod. RastDHB · Traditional | Incstar Corp. | 10/20/1987SE |
| K873770 | Bermuda Grass Allergen DiscDHB · Traditional | Incstar Corp. | 10/20/1987SE |
| K873112 | Phadebas Rast/Phadezym Rast Allergen DiscDHB · Traditional | Pharmacia, Inc. | 10/20/1987SE |
| K872946 | Phadebas Rast/Phadezym Rast Allergen DiscDHB · Traditional | Pharmacia, Inc. | 10/20/1987SE |
| K873648 | Bahia Allergen DiscDHB · Traditional | Incstar Corp. | 10/08/1987SE |
| K873193 | Phadebas Rast/Phadezym Rast Allergen DiscsDHB · Traditional | Pharmacia, Inc. | 10/08/1987SE |
| K873676 | Ige Immuno Response Test (Irt) Calibrator UnitDHB · Traditional | Incstar Corp. | 10/07/1987SE |
| K873486 | Red Top Allergen DiscDHB · Traditional | Incstar Corp. | 10/07/1987SE |
| K872280 | Modified Phadebas Rast/Phadezym RastDHB · Traditional | Pharmacia, Inc. | 10/07/1987SE |
| K873406 | RRT Short Ragweed Test KitDHB · Traditional | Incstar Corp. | 09/23/1987SE |
| K871684 | Alternaria Tenuis Allergen DiscDHB · Traditional | Incstar Corp. | 07/16/1987SE |
| K871723 | Sweet Vernal Allergen DiscDHB · Traditional | Incstar Corp. | 07/13/1987SE |
| K871599 | Delfia(Tm) Hige KitDHB · Traditional | Lkb Instruments, Inc. | 06/12/1987SE |
| K871660 | Western Ragweed Allergen DiscDHB · Traditional | Incstar Corp. | 05/14/1987SE |
| K870625 | Ivt Southwest Allergy ScreenDHB · Traditional | In Vitro Technologies, Inc. | 05/01/1987SE |
| K871331 | Ventrescreen Cat/Dog Allergy Test Kit Enzyme Immu.DHB · Traditional | Ventrex Laboratories, Inc. | 04/28/1987SE |
| K870966 | Total Ige MastickDHB · Traditional | Mast Immunosystems | 04/14/1987SE |
| K870009 | Ventrescreen Mite/Mold Allergy Test Kit Enzyme Im.DHB · Traditional | Ventrex Laboratories, Inc. | 04/14/1987SE |
| K870624 | Ventrex Ip Specific E Enzyme ImmunoassayDHB · Traditional | Ventrex Laboratories, Inc. | 03/24/1987SE |
| K864696 | Allerg*Ens Enzyme Immunoassay KitDHB · Traditional | Dexall Biomedical Labs, Inc. | 03/17/1987SE |
| K870597 | D. Farinae Allergen DiscDHB · Traditional | Incstar Corp. | 03/04/1987SE |
| K870264 | Cat Epithelium Allergen DiscDHB · Traditional | Incstar Corp. | 02/13/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0814-2026 Class II | Pollen Allergy TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0813-2026 Class II | Pet Allergy TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0808-2026 Class II | Food Intolerance Test SmallDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0807-2026 Class II | Food Intolerance Test MediumDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0806-2026 Class II | Food Intolerance Test LargeDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0803-2026 Class II | Allergy test SmallDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0769-2026 Class II | Allergy Test IgEDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0762-2026 Class II | Food Sensitivity Test SmallDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0761-2026 Class II | Food Sensitivity Test MediumDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0760-2026 Class II | Food Sensitivity Test LargeDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0759-2026 Class II | Food Allergy Panel Test (IgE)Distribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0493-2026 Class II | Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number:…The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen… | Siemens Healthcare Diagnostics, Inc. | 10/06/2025Open, Classified |
| Z-0492-2026 Class II | 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor…The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen… | Siemens Healthcare Diagnostics, Inc. | 10/06/2025Open, Classified |
| Z-0491-2026 Class II | IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105…The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen… | Siemens Healthcare Diagnostics, Inc. | 10/06/2025Open, Classified |
| Z-0718-2023 Class II | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material…Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and… | Siemens Healthcare Diagnostics, Inc. | 11/04/2022Open, Classified |
| Z-0717-2023 Class II | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan…Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and… | Siemens Healthcare Diagnostics, Inc. | 11/04/2022Open, Classified |
| Z-0716-2023 Class II | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens…Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and… | Siemens Healthcare Diagnostics, Inc. | 11/04/2022Open, Classified |
| Z-2397-2019 Class II | Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and…code 7-102 Liquid Sensor Error | Phadia Ab | 07/09/2019Terminated |
| Z-0224-2020 Class II | HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution…Some of the Stop Solution bottles, a caustic solution, have been reported to leak. | Hycor Biomedical LLC | 07/25/2018Open, Classified |
| Z-1674-2018 Class II | IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal KitConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-1313-2018 Class II | ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific…The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met. | Phadia US Inc | 12/18/2017Terminated |
| Z-1312-2018 Class II | ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE…The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met. | Phadia US Inc | 12/18/2017Terminated |
| Z-1276-2018 Class II | Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia…We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All… | Phadia Ab | 11/20/2017Terminated |
| Z-0387-2018 Class II | Phadia 1000 Instrument, Article Number 12-3800-01.The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and… | Phadia US Inc | 07/05/2017Terminated |
| Z-1843-2015 Class II | IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test)…IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the… | Siemens Healthcare Diagnostics, Inc. | 05/06/2015Terminated |
| Z-0947-2015 Class II | Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All…During an investigation of instrument logs it was determined that In specific circumstances involving… | Phadia US Inc | 11/20/2014Terminated |
| Z-0793-2013 Class III | OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi…There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low… | Hitachi Chemical Diagnostics Inc | 12/21/2012Terminated |