Eonis SCID-SMA kit 3241-001U

GUDID 06438147377732

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

Wallac Oy

Multiple primary immunodeficiency/congenital muscular disorder IVD, kit, nucleic acid technique (NAT) Multiple primary immunodeficiency/congenital muscular disorder IVD, kit, nucleic acid technique (NAT) Multiple primary immunodeficiency/congenital muscular disorder IVD, kit, nucleic acid technique (NAT) Multiple primary immunodeficiency/congenital muscular disorder IVD, kit, nucleic acid technique (NAT) Multiple primary immunodeficiency/congenital muscular disorder IVD, kit, nucleic acid technique (NAT) Multiple primary immunodeficiency/congenital muscular disorder IVD, kit, nucleic acid technique (NAT) Multiple primary immunodeficiency/congenital muscular disorder IVD, kit, nucleic acid technique (NAT) Multiple primary immunodeficiency/congenital muscular disorder IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 06438147377732
• NIH Device Record Key: 36c600ec-87ee-4898-991e-5281f3808c28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eonis SCID-SMA kit
• Version Model Number: 3241-001U
• Catalog Number: 3241-001U
• Company DUNS: 540156544
• Company Name: Wallac Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147377732 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200044

FDA Product Code

• QUE: Spinal Muscular Atrophy Newborn Screening Test System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [Eonis SCID-SMA kit]

• 06438147377756: The Eonis SCID-SMA kit is a device intended for PCR amplification of sjTREC, KREC, SMN1 and RPP3
• 06438147377732: The Eonis SCID-SMA kit is a device intended for PCR amplification of sjTREC, KREC, SMN1 and RPP3