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OPTIGEN® Positive Control Reagent

FDA UDI

Class II (US FDA UDI)

by Minaris Medical America, Inc.

Identity

Trade Name
OPTIGEN® Positive Control Reagent FDA UDI
Generic Name
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control FDA UDI
Device Name
OPTIGEN Positive Control FDA UDI
Model / Reference
82061 FDA UDI
Description
OPTIGEN Positive Control FDA UDI

Identifiers

Catalog Number
82061 FDA UDI
Primary DI / UDI-DI
00813382010082 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
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

Category: Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control

OPTIGEN® Positive Control Reagent by Minaris Medical America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control.

Cleared under the same submission

K051677 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Minaris Medical America, Inc.

Sources (1)

  • FDA UDI 6c48a51c-530c-4595-ba54-5b791074a364 37 fields · synced Jun 8, 2026