Identity
- Trade Name
- IFE IgD Antiserum FDA UDI
- Generic Name
- Immunoglobulin D subclass (IgD subclass) IVD, reagent FDA UDI
- Model / Reference
- 9419 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52594190 FDA UDI
- 510(k) Number
- K872834 FDA UDI
- FDA Product Code
- CZJ FDA UDI
- GMDN Term
- Immunoglobulin D subclass (IgD subclass) 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Immunoglobulin D subclass (IgD subclass) IVD, reagent
IFE IgD Antiserum by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunoglobulin D subclass (IgD subclass) IVD, reagent.
- IFE IgD Antiserum — Helena Laboratories, Corp. · Class II
- Antiserum to Human IgD — Helena Laboratories, Corp. · Class II
Cleared under the same submission
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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI 3736ac69-8c2a-45d0-a2f0-daa4660a7182 34 fields · synced Jun 9, 2026