Identity
- Trade Name
- IgE FDA UDI
- Generic Name
- Allergen-specific/total immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
- Device Name
- An IgE test system is a device intended for the quantitative in vitro determination of immunoglobulin E (IgE) concentration in human serum or plasma FDA UDI
- Model / Reference
- IE7308 FDA UDI
- Description
- An IgE test system is a device intended for the quantitative in vitro determination of immunoglobulin E (IgE) concentration in human serum or plasma FDA UDI
Identifiers
- Catalog Number
- IE7308 FDA UDI
- Primary DI / UDI-DI
- 05055273203929 FDA UDI
- 510(k) Number
- K010855 FDA UDI
- FDA Product Code
- DGC FDA UDI
- GMDN Term
- Allergen-specific/total immunoglobulin E (IgE) antibody IVD, reagent 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
No
FDA UDI
Category: Allergen-specific/total immunoglobulin E (IgE) antibody IVD, reagent
IgE by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K010855 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 |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 83051e12-3208-45f3-a9b0-220f2a73114d 37 fields · synced Jun 1, 2026