Identity
- Trade Name
- UP20 Positive Control Reagent FDA UDI
- Generic Name
- Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control FDA UDI
- Device Name
- UP20 Positive Control Reagent FDA UDI
- Model / Reference
- 80107 FDA UDI
- Description
- UP20 Positive Control Reagent FDA UDI
Identifiers
- Catalog Number
- 80107 FDA UDI
- Primary DI / UDI-DI
- 00813382010280 FDA UDI
- 510(k) Number
- K051677 FDA UDI
- FDA Product Code
- DGC FDA UDI
- GMDN Term
- Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 FDA UDI
- Commercial Distribution
- Not 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
No
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
UP20 Positive Control Reagent by Minaris Medical America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 Inhalant 36 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 4075dc92-9ec3-43dc-b79c-7aa08225e5f6 38 fields · synced May 31, 2026