EasyScreen™ Sample Processing Kit SP001

GUDID 09351179000225

The EasyScreen™ Sample Processing Kit (SP001) is a kit that contains reagents to isolate, sodium bisulphite treat and purify nucleic acids from clinical specimens or bacterial cultures. The nucleic acids can then be used with compatible EasyScreen™ Detection Kits for various microorganisms.

GENETIC SIGNATURES LIMITED

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 09351179000225
• NIH Device Record Key: 48551a01-fcfc-4a02-9a2b-9ad577344182
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyScreen™ Sample Processing Kit
• Version Model Number: 1
• Catalog Number: SP001
• Company DUNS: 741249601
• Company Name: GENETIC SIGNATURES LIMITED
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +61298707580
• Email: northamerica@geneticsignatures.com
• Phone: +61298707580
• Email: northamerica@geneticsignatures.com
• Phone: +61298707580
• Email: northamerica@geneticsignatures.com
• Phone: +61298707580
• Email: northamerica@geneticsignatures.com
• Phone: +61298707580
• Email: northamerica@geneticsignatures.com
• Phone: +61298707580
• Email: northamerica@geneticsignatures.com
• Phone: +61298707580
• Email: northamerica@geneticsignatures.com
• Phone: +61298707580
• Email: northamerica@geneticsignatures.com
• Phone: +61298707580
• Email: northamerica@geneticsignatures.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351179000225 [Primary]

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: 2024-12-11
• Device Publish Date: 2024-12-03

On-Brand Devices [EasyScreen™ Sample Processing Kit ]

• 09351179000188: The EasyScreen™ Sample Processing Kit (SP008B) is designed to rapidly isolate nucleic acids (D
• 09351179000003: The EasyScreen™ Sample Processing Kit (SP012) is designed to rapidly isolate nucleic acids (DN
• 09351179000225: The EasyScreen™ Sample Processing Kit (SP001) is a kit that contains reagents to isolate, sodi