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OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (40ND)

FDA UDI

Class II (US FDA UDI)

by Minaris Medical America, Inc.

Identity

Trade Name
OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (40ND) FDA UDI
Generic Name
Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
KIT, OPTIGEN US Environmental 36 (40ND) FDA UDI
Model / Reference
85168 FDA UDI
Description
KIT, OPTIGEN US Environmental 36 (40ND) FDA UDI

Identifiers

Catalog Number
85168 FDA UDI
Primary DI / UDI-DI
00813382012178 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 Environmental 36 (40ND) 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.

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 051708c1-1a37-4072-b56d-6963e9bb3026 35 fields · synced Jun 6, 2026