Identity
- Trade Name
- CLA® Allergen-Specific IgE Assay - Eastern FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- KIT, Eastern FDA UDI
- Model / Reference
- 84502 FDA UDI
- Description
- KIT, Eastern FDA UDI
Identifiers
- Catalog Number
- 84502 FDA UDI
- Primary DI / UDI-DI
- 00813382010105 FDA UDI
- 510(k) Number
- K823593 FDA UDIK833885 FDA UDIK834526 FDA UDIK843694 FDA UDIK926420 FDA UDIK934524 FDA UDI
- FDA Product Code
- DHB FDA UDI
- GMDN Term
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
CLA® Allergen-Specific IgE Assay - Eastern by Minaris Medical America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay.
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Cleared under the same submission
K823593 also covers:
K833885 also covers:
K834526 also covers:
K843694 also covers:
K926420 also covers:
K934524 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Minaris Medical America, Inc.
Sources (1)
- FDA UDI 85059b2a-ffe5-497a-8702-8931bf2f18c4 37 fields · synced Jun 1, 2026