Identity
- Trade Name
- IgE Reference Disc FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
- Model / Reference
- 74118 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816879022292 FDA UDI
- FDA Product Code
- DHB FDA UDI
- GMDN Term
- Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5750 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
IgE Reference Disc by Hycor Biomedical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Hycor Biomedical Llc
Sources (1)
- FDA UDI a3c25146-b67f-40ac-bb21-4c6272097c7c 34 fields · synced Jun 1, 2026