Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunoca…
FDA 510(k)Class II (US FDA 510(k))
by Phadia AB
Identifiers
- 510(k) Number
- K101251 FDA 510(k)
- FDA Product Code
- DHB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5750 FDA 510(k)
- Regulation Number
- 866.5750 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ImmunoCAP Allergen D202 and D203 are in vitro diagnostic devices classified as System, Test, Radioallergosorbent (RAST) Immunological. These assays are designed to detect allergen-specific immunoglobulin E (IgE) antibodies in human serum or plasma, specifically targeting components of house dust mite allergens, including rDer p 1 (allergen component NDER P 1). They function using a solid-phase immunoassay principle to quantify sensitization at the molecular level, aiding in the diagnosis of allergic conditions.
These devices are intended for use in clinical laboratories and are supplied as single-use diagnostic kits. The ImmunoCAP system operates under FDA 510(k) clearance (K101251) and is categorized under Device Class II (regulation number 866.5750). The allergen components are pre-coated on solid-phase carriers, requiring no additional preparation beyond standard laboratory procedures. Storage and handling follow standard in vitro diagnostic protocols, ensuring sterility and stability for single-use applications. No MRI safety considerations apply, as these are laboratory-based assays.
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™ Mite Allergen Components d202 | Request for Quote | Thermo ..., ImmunoCAP Allergen component rDer p 1, House dust mite, ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101251 | Class II | Active |
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Manufacturer
- Manufacturer
- Phadia AB
Sources (1)
- FDA 510(k) K101251 24 fields · synced Sep 20, 2026