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OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36(100 ND)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36(100 ND) FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- KIT, OPTIGEN US Inhalant 36 (100 ND) FDA UDI
- Model / Reference
- 85081 FDA UDI
- Description
- KIT, OPTIGEN US Inhalant 36 (100 ND) FDA UDI
Identifiers
- Catalog Number
- 85081 FDA UDI
- Primary DI / UDI-DI
- 00813382010426 FDA UDI
- FDA Product Code
- PUW 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
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
Yes
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: Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36(100 ND) by Minaris Medical America, Inc. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay.
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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
- Minaris Medical America, Inc.
Sources (1)
- FDA UDI cebb3ff1-526f-40bf-ac13-33edf457f57b 36 fields · synced May 30, 2026