Identity
- Trade Name
- Anti Human IgE FITC FDA UDI
- Generic Name
- Total immunoglobulin E (IgE total) IVD, antibody FDA UDI
- Device Name
- Fluorescein conjugated polyclonal goat antiserum to Human IgE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Fluorescein conjugated polyclonal goat antiserum to Human IgE FDA UDI
Identifiers
- Catalog Number
- 104202 FDA UDI
- Primary DI / UDI-DI
- B1761042 FDA UDI
- FDA Product Code
- DGP FDA UDI
- GMDN Term
- Total immunoglobulin E (IgE total) IVD, antibody 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total immunoglobulin E (IgE total) IVD, antibody
Anti Human IgE FITC by Kent Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin E (IgE total) IVD, antibody.
- IgE / FITC GPab — BIO SB, INC. · Class I
- Sheep Anti-Human IgE Immunofixation Grade — The Binding Site Group · Class II
- Poly Rb A-Hu IgE — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Antiserum to Human IgE (epsilon specific) — KENT LABORATORIES, INC. · Class II
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
- Kent Laboratories, Inc.
Sources (1)
- FDA UDI b8c697ad-31fa-4289-9be6-112adbf3d6fd 36 fields · synced May 30, 2026