Identity
- Trade Name
- Allereye® Tear Total IgE Test Kit FDA UDI
- Generic Name
- Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Allereye® is a rapid immunoassay for the detection of total IgE in tears. FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- Allereye® is a rapid immunoassay for the detection of total IgE in tears. FDA UDI
Identifiers
- Catalog Number
- 380003G FDA UDI
- Primary DI / UDI-DI
- 00864525000408 FDA UDI
- GMDN Term
- Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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
No
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, kit, enzyme immunoassay (EIA)
Allereye® Tear Total IgE Test Kit by Bluejay Diagnostics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA).
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Bluejay Diagnostics, Inc.
Sources (1)
- FDA UDI 5627acca-3b23-428a-aa60-5c573c822fd4 35 fields · synced Jun 1, 2026