← Back to catalogue

CLA® Allergen-Specific IgE Assay - Southwestern Inhalant Panel

FDA UDI

Class II (US FDA UDI)

by Minaris Medical America, Inc.

Identity

Trade Name
CLA® Allergen-Specific IgE Assay - Southwestern Inhalant Panel FDA UDI
Generic Name
Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
KIT, Southwestern Inhalant FDA UDI
Model / Reference
84509 FDA UDI
Description
KIT, Southwestern Inhalant FDA UDI

Identifiers

Catalog Number
84509 FDA UDI
Primary DI / UDI-DI
00813382010150 FDA UDI
510(k) Number
K823593 FDA UDI
K833885 FDA UDI
K834526 FDA UDI
K843694 FDA UDI
K926420 FDA UDI
K934524 FDA UDI
FDA Product Code
DHB 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
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

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

CLA® Allergen-Specific IgE Assay - Southwestern Inhalant Panel by Minaris Medical America, Inc. — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K823593 also covers:

K833885 also covers:

K834526 also covers:

K843694 also covers:

K926420 also covers:

K934524 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Minaris Medical America, Inc.

Sources (1)

  • FDA UDI b73d6c6f-86ce-4393-99e1-561f4d111a98 38 fields · synced May 30, 2026