Identity
- Trade Name
- Immunoglobulin E (IgE) ELISA FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients. FDA UDI
- Model / Reference
- EIA-1788 FDA UDI
- Description
- The DRG IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients. FDA UDI
Identifiers
- Catalog Number
- EIA-1788 FDA UDI
- Primary DI / UDI-DI
- 04048474017885 FDA UDI
- 510(k) Number
- K992528 FDA UDI
- FDA Product Code
- DGC 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
- 866.5510 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Immunoglobulin E (IgE) ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — 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).
- ImmunoCAP Allergen w1, Common ragweed — Phadia GmbH · Class II
- NOVEOS IgE Calibrator Set — HYCOR BIOMEDICAL LLC · Class II
- ImmunoCAP Antigen RGm22, Micropolyspora faeni — Phadia GmbH · Class I
- ImmunoCAP Allergen k74, Silk — Phadia GmbH · Class II
- ImmunoCAP Allergen i72, Green nimitti — Phadia GmbH · Class II
- ImmunoCAP Allergen Rw23, Yellow dock — Phadia GmbH · Class I
- ImmunoCAP Allergen Rm220, Allergen component rAsp f 3 Aspergillus fumigatus — Phadia GmbH · Class I
- ImmunoCAP Allergen Rf304, Langust (spiny lobster) — Phadia GmbH · Class I
Cleared under the same submission
K992528 also covers:
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
Sources (1)
- FDA UDI a3a8add2-9e99-4f3c-a197-b95ab7c51e53 37 fields · synced Jun 8, 2026