DHB

Product Code: DHB


Products Classified as DHB

2996System, Test, Radioallergosorbent (rast) ImmunologicalRadioallergosorbent (RAST) Immunological Test System.

Total Product Life Cycle (TPLC) Devices

2996System, Test, Radioallergosorbent (rast) ImmunologicalRadioallergosorbent (RAST) Immunological Test System.

FDA Consensus Standards

System, Test, Radioallergosorbent (Rast) Immunological [35710]21 CFR §866.5750 🔎

Pre-market Notifications for DHB

K220162Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, AlternariaHycor Biomedical
K212181ImmunoCAP 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 SeedPhadia AB
K200825NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum PratenseHycor Biomedical
K200279ImmunoCAP Allergen O215, Component NGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, BovinePhadia AB
K191510Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides FarinaeHycor Biomedical
K190315ImmunoCAP 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 CatPhadia AB
K182479NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides PteronyssinusHycor Biomedical
K173726ImmunoCAP Specific IgE, ImmunoCAP Allergen F447, Allergen Component RAra H 6, PeanutPhadia AB
K163370ImmunoCAP Allergen W1, Common Ragweed; ImmunoCAP Specific IgEPHADIA AB
K151029Phadia PrimePHADIA AB
K150854ImmunoCAP Specific IgE; ImmunoCAP Allergen F439, Hazelnut; ImmunoCAP Allergen F440, Hazelnut; ImmunoCAP Allergen F441, Walnut; ImmunoCAP Allergen F442, Walnut; ImmunoCAP Allergen F443, Cashew NutPHADIA AB
K150597ImmunoCAP Allergen D202, Allergen Component RDer P 1,House Dust MitePHADIA AB
K132801IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAYSiemens Healthcare Diagnostics Inc.
K131738IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL HPHADIA AB
K123275IMMUNOCAP ALLERGEN I3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN I4, PAPER WASP VENOMPHADIA AB

Global Unique Device Identification Database

00630414996615SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996608SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996592SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996585SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996578SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996561SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996554SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996547SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996530SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996523SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996516SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996509SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996493SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996486SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
00630414996479SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

Maude Adverse Events

IMMULITE 2000 XPI - SPESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2019-07-11
IMMULITE 2000 XPI - SPESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2019-07-11
IMMULITE 2000 XPI - SPESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2019-06-07
IMMULITE 2000 XPI - SPESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2019-06-07
SPECIFIC/TOTAL IGE EIAHYCOR BIOMEDICAL2018-07-11
IMMULITE 2000 3GALLERGY SPECIFIC IGESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2018-05-29
IMMULITE 2000 3GALLERGY SPECIFIC IGESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2018-05-22
IMMULITE 2000 3GALLERGY SPECIFIC IGESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2018-05-22
SPECIFIC/TOTAL IGE EIAHYCOR BIOMEDICAL2018-04-16
IMMULITE 2000 3GALLERGY SPECIFIC IGESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2018-02-26
IMMULITE 2000/IMMULITE 2000 XPI 3G ALLERGEN SPECIFIC IGESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2017-12-14
IMMULITE 2000 3GALLERGY SPECIFIC IGESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2017-12-04
IMMULITE 2000 3GALLERGY SPECIFIC IGESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2017-12-04
IMMULITE 2000 3GALLERGY SPECIFIC IGESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2017-12-04
HYTEC 288 PROBE CLEANING SOLUTIONHYCOR BIOMEDICAL2017-10-25
SPECIFIC/TOTAL IGE EIAHYCOR BIOMEDICAL2017-10-20
IMMULITE 2000 3GALLERGY SPECIFIC IGESIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2017-10-19
IMMULITE 2000 WHITE ASHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2017-08-04
IMMULITE 2000 WHITE ASHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2017-08-04
IMMULITE 2000 WHITE ASHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2017-08-04
IMMULITE 2000 WHITE ASHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2017-08-04
IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.2015-06-09
IMMULITE 2000 XPISIEMENS HEALTHCARE DIAGNOSTICS2012-09-04
IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KITSIEMENS HEALTHCARE DIAGNOSTICS2012-01-09
IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KITSIEMENS HEALTHCARE DIAGNOSTICS2011-12-16
IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAYSIEMENS MEDICAL DIAGNOSTICS, INC.2008-10-15
TRUEGLAXO WELLCOME, INC.1998-12-17

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