ImmunoCAP Total IgE: Conjugate, Anti-IgE, Calibrators, Curve Controls, Control LMH

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K133404

Identifiers

510(k) Number: K133404 FDA 510(k)
FDA Product Code: DGC FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 866.5510 FDA 510(k)
Regulation Number: 866.5510 FDA 510(k)
Advisory Committee: Immunology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The ImmunoCAP Total IgE is an in vitro diagnostic device used for the quantitative measurement of total Immunoglobulin E (IgE) in human serum or plasma. It employs immunoassay technology to detect and quantify IgE levels, aiding in the diagnosis and monitoring of allergic conditions, including asthma, allergic rhinitis, and atopic dermatitis.

This device is supplied as a reagent kit, including conjugates, anti-IgE antibodies, calibrators, curve controls, and a low-moderate-high (LMH) control. It is intended for single-use and requires no special storage conditions beyond refrigeration. The device is authorized under FDA 510(k) clearance and IVDR compliance, adhering to regulatory standards for in vitro diagnostic reagents in immunology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ImmunoCAP Total IgE Anti-IgE - Thermo Fisher Scientific, ImmunoCAP Total IgE (Calibrator, Curve Controls) - Thermo Fisher Scientific, Thermo Scientific ImmunoCAP Total IgE Reagents for Phadia 5000/2500 ..., Immunocap Total Ige: Conjugate, Anti-ige, Calibrators, Curve Controls ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K133404	Class II	Active

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Manufacturer

Manufacturer: Phadia AB

Sources (2)

FDA 510(k) K133404 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026