Identity
- Trade Name
- ImmunoCAP Specific IgE 0-100 FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Contains one bottle of Specific IgE Conjugate and two vials of each Specific IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgE method. FDA UDI
- Model / Reference
- 10-9462-02 FDA UDI
- Description
- Contains one bottle of Specific IgE Conjugate and two vials of each Specific IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgE method. FDA UDI
Identifiers
- Catalog Number
- 10-9462-02 FDA UDI
- Primary DI / UDI-DI
- 07333066019666 FDA UDI
- 510(k) Number
- K051218 FDA UDI
- FDA Product Code
- DHB FDA UDI
- GMDN Term
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Specific IgE 0-100 by Phadia GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA).
- NOVEOS IgE Calibrator Set — HYCOR BIOMEDICAL LLC · Class II
- NOVEOS Fluo Beads — HYCOR BIOMEDICAL LLC · Class II
- NOVEOS Conjugate IgE — HYCOR BIOMEDICAL LLC · Class II
- Immunoglobulin E (IgE) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Immunoglobulin E (IgE) ELISA — DRG International, Inc. · Class II
- NOVEOS IgE Calibrator Antibody Pack — HYCOR BIOMEDICAL LLC · Class II
- ImmunoCAP Allergen w1, Common ragweed — Phadia GmbH · Class II
- ImmunoCAP Antigen RGm22, Micropolyspora faeni — Phadia GmbH · Class I
Cleared under the same submission
K051218 also covers:
- ImmunoCAP Allergen f57, Japanese millet — Phadia GmbH
- ImmunoCAP Allergen fx9, Food — Phadia GmbH
- ImmunoCAP Allergen i72, Green nimitti — Phadia GmbH
- ImmunoCAP Allergen k74, Silk — Phadia GmbH
- ImmunoCAP Allergen w1, Common ragweed — Phadia GmbH
- ImmunoCAP Specific IgE Calibrators 0-100 — Phadia GmbH
- Phadia 100 — Phadia GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phadia GmbH
Sources (1)
- FDA UDI 98b49153-2746-452c-8c28-3acfa77506fe 37 fields · synced May 30, 2026