EasyScreen™ Sample Processing Kit SP012

GUDID 09351179000003

The EasyScreen™ Sample Processing Kit (SP012) is designed to rapidly isolate nucleic acids (DNA and RNA) from clinical samples via an automated purification system. Reagents are supplied to convert all nucleic acids into 3base™ sequences and to perform the subsequent purification on supported platforms (Genetic Signatures GS1). The purified nucleic acids are compatible with the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). This kit includes all reagents required to take a sample from the specimen, lyse any microorganisms, convert the nucleic acid into 3base™ form and purify the nucleic acids using magnetic beads. This kit is designed to be used in hospital and pathology laboratories or similar by trained personnel. This kit does not produce any results, but it is a necessary requirement for the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005).

GENETIC SIGNATURES LIMITED

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 09351179000003
• NIH Device Record Key: ac1df530-8498-447e-9065-4062c9874298
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyScreen™ Sample Processing Kit
• Version Model Number: 1
• Catalog Number: SP012
• 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
• 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
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351179000003 [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: 2024-11-26
• Device Publish Date: 2024-11-18

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