Eonis SCID-SMA kit

Basic Information

• Brand Name: Eonis SCID-SMA kit
• Primary DI: 06438147377732
• Version / Model: 3241-001U
• Catalog Number: 3241-001U
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 1
• Public Version Date: 2022-12-08
• Public Version Status: New
• Public Device Record Key: 36c600ec-87ee-4898-991e-5281f3808c28

Device Description

The Eonis SCID-SMA kit is a device intended for PCR amplification of sjTREC, KREC, SMN1 and RPP30 DNAs.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QUE	Spinal Muscular Atrophy Newborn Screening Test System	Immunology	866.5980	2
PJI	Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System	Immunology	866.5930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64820	Multiple primary immunodeficiency/congenital muscular disorder IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict multiple inborn immunodeficiencies [e.g., X-linked agammaglobulinaemia, severe combined immunodeficiency (SCID)] and congenital muscular disorders (e.g., spinal muscular atrophy) using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147377732	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN200044	000
K203035	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – -16 Degrees Celsius