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IMMULITE®2000 Systems 3gAllergy™ House Dust Panel 1

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE®2000 Systems 3gAllergy™ House Dust Panel 1 FDA UDI
Generic Name
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
Device Name
Dust Panel 1 - IMMULITE - RGT - 40 test FDA UDI
Model / Reference
10385948 FDA UDI
Description
Dust Panel 1 - IMMULITE - RGT - 40 test FDA UDI

Identifiers

Catalog Number
HP1L4 FDA UDI
Primary DI / UDI-DI
00630414960678 FDA UDI
510(k) Number
K013135 FDA UDI
FDA Product Code
DHB FDA UDI
GMDN Term
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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 immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ House Dust Panel 1 by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent.

Cleared under the same submission

K013135 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI 0ec12865-74f3-4b6a-93b0-1c5be24818ef 37 fields · synced Jun 8, 2026