← Back to catalogue

Helios

FDA UDI

Class II (US FDA UDI)

by Aesku Systems GmbH&Co.Kg

Identity

Trade Name
HELIOS FDA UDI
Generic Name
Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Device Name
Automated system for immunofluorescence processing with an integral fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions. FDA UDI
Model / Reference
AUTOMATED IFA SYSTEM FDA UDI
Description
Automated system for immunofluorescence processing with an integral fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions. FDA UDI

Identifiers

Catalog Number
IOS-1000 FDA UDI
Primary DI / UDI-DI
04260186125096 FDA UDI
FDA Product Code
PIV FDA UDI
DHN FDA UDI
GMDN Term
Fluorescent immunoassay analyser IVD, laboratory FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.4750 FDA UDI
866.5100 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Fluorescent immunoassay analyser IVD, laboratory

Helios by Aesku Systems GmbH&Co.Kg — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluorescent immunoassay analyser IVD, laboratory.

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
Aesku Systems GmbH&Co.Kg

Sources (1)

  • FDA UDI 53c87a5d-6ffb-45c8-93f5-2517f770e335 34 fields · synced Jun 7, 2026