Eonis Analysis software

Basic Information

• Brand Name: Eonis Analysis software
• Primary DI: 06438147373901
• Version / Model: 5020-1000
• Catalog Number: 5020-1000
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: 98b50e7e-f49a-404e-aac9-9ce0184a4f3a

Device Description

The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eonis PCR Reagent Kit for the semi-quantitative determination of TREC (signal joint T-cell receptor excision circle)and KREC (Kappa-deleting recombination excision circle), as well as the qualitative detection of the exon 7 of SMN1gene and RPP30 (Ribonuclease P/MRP Subunit P30) gene in DNA from blood specimens dried on a filter paper as an aidin screening newborns for Severe Combined Immunodeficiency (SCID), X-linked agammaglobulinemia (XLA) and SpinalMuscular Atrophy (SMA).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	862.2100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65871	Human genomic analysis interpretive software IVD	An in vitro diagnostic interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic results obtained through molecular genetic testing (e.g., whole genome, targeted genome, or exome analyses). It provides predictive and/or diagnostic information (e.g., gene-drug associations, congenital and/or acquired aneuploidy status, genotype-phenotype relationships) used by a professional in the assessment of patient adverse health condition risk, disease prevention, and/or health management, or for lifestyle guidance as pertains to a patient genomic profile.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147373901	GS1