Eonis DNA Extraction kit 3240-001U

GUDID 06438147377718

The Eonis DNA Extraction kit is a device intended for isolation and purification of DNA in newborn blood specimens dried on filter paper.

Wallac Oy

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 06438147377718
• NIH Device Record Key: 2aaa12ca-8b59-4268-97c7-10739bff678c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eonis DNA Extraction kit
• Version Model Number: 3240-001U
• Catalog Number: 3240-001U
• Company DUNS: 540156544
• Company Name: Wallac Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 19 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147377718 [Primary]

FDA Product Code

• JJH: Clinical Sample Concentrator

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

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• 06438147377718 - Eonis DNA Extraction kit: 2022-12-08The Eonis DNA Extraction kit is a device intended for isolation and purification of DNA in newborn blood specimens dried on filter paper.
• 06438147377718 - Eonis DNA Extraction kit: 2022-12-08 The Eonis DNA Extraction kit is a device intended for isolation and purification of DNA in newborn blood specimens dried on filt