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OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36 Panel
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36 Panel FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- KIT, OPTIGEN US Inhalant 36 FDA UDI
- Model / Reference
- 85063 FDA UDI
- Description
- KIT, OPTIGEN US Inhalant 36 FDA UDI
Identifiers
- Catalog Number
- 85063 FDA UDI
- Primary DI / UDI-DI
- 00813382010372 FDA UDI
- 510(k) Number
- K051677 FDA UDI
- FDA Product Code
- PUW FDA UDIDHB 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
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 immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36 Panel by Minaris Medical America, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay.
- IMMULITE® 2000 Systems SPE Specific IgE Universal Kit — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- OPTIGEN® Allergen-Specific IgE Assay - US Food 30 (40ND) — Minaris Medical America, Inc. · Class II
- OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36(100 ND) — Minaris Medical America, Inc. · Class II
- OPTIGEN® Allergen-Specific IgE Assay - Environmental 36 (20T) — Minaris Medical America, Inc. · Class II
- CLA® Allergen-Specific IgE Assay - Moderate Food Panel — Minaris Medical America, Inc. · Class II
- OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND) — Minaris Medical America, Inc. · Class II
- OPTIGEN® Allergen-Specific IgE Assay - US Mix 36 Panel — Minaris Medical America, Inc. · Class II
- CLA® Allergen-Specific IgE Assay - Eastern — Minaris Medical America, Inc. · Class II
Cleared under the same submission
K051677 also covers:
- OPTIGEN® Allergen-Specific IgE Assay - US Food 20 Panel — Minaris Medical America, Inc.
- OPTIGEN® Allergen-Specific IgE Assay - US Mix 36 Panel — Minaris Medical America, Inc.
- OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel — Minaris Medical America, Inc.
- OPTIGEN® Negative Control Reagent — Minaris Medical America, Inc.
- OPTIGEN® Positive Control Reagent — Minaris Medical America, Inc.
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 0efdf9af-e188-4dcc-97b9-98ca82ae7ce0 37 fields · synced May 30, 2026