FDA.reportPublic FDA data

HELMED

Primary DI
04260186125003
Brand
HELMED
Company
Aesku.Systems GmbH & Co. KG
Model
HELMED IFA PROCESSOR KIT
Catalog number
HEL-1000
Device description
Automated IFA Processor
Published
2020-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JQWStation, Pipetting And Diluting, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQWStation, Pipetting And Diluting, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
42601861205007PreviousGS10
04260186125003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4260186120500742601861205007
04260186125003042601861250034260186125003

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality clinical specimen analysis system IVDAn assembly of mains electricity (AC-powered) devices consisting of two or more analysers of different analytic modalities [e.g., immunoassay and photometric (clinical chemistry)] intended to be used for the qualitative and/or quantitative determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin, electrolytes) in a clinical specimen. The assembly may also include a sample preparation instrument, reagent management instrument, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341702675
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260186125096HELIOSAUTOMATED IFA SYSTEMIOS-10002020-03-02
42601861205090HELIOSAUTOMATED IFA SYSTEMIOS-10002016-09-27
42601861205007HELMEDHELMED® IFA PROCESSOR KITHEL-10002016-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026392Diagnostic Automation, Inc.Diagnostic Automation, Inc.JQW2025-12-24
08059304340147dIFine P15VISIA LAB SRLJQW2025-06-27
00884999051522Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999048973Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999051508Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999051515Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999051720Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
06975379910028QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
06975379910035QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
06975379910509QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
16975379910025QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
16975379910032QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
16975379910506QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
06975379910011QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-13
16975379910018QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-13
06975379910004QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-12
07640137480288Veya Dx 6Tecan Schweiz AGJQW2025-03-31
07640137480295Veya Dx 9Tecan Schweiz AGJQW2025-03-31
07613336180112AVENIO Edge SystemRoche Molecular Systems, Inc.JQW2025-03-25
00819704020388FINDERBaebies, Inc.JQW2025-01-31
00819704020395FINDERBaebies, Inc.JQW2025-01-31
07613336155790AcfS L and D Equipment Installation BundleRoche Molecular Systems, Inc.JQW2025-01-30
07613336172353AcfS Library RobotRoche Molecular Systems, Inc.JQW2025-01-30
07613336172360AcfS Detection RobotRoche Molecular Systems, Inc.JQW2025-01-30
04250289513531HELMED® Automated IFA ProcessorAesku.Diagnostics GmbH & Co. KGJQW2025-01-03
00812589020979FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021051FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021068FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021075FontusCaliper Life Sciences, Inc.JQW2024-07-02
00812589021082FontusCaliper Life Sciences, Inc.JQW2024-07-02