EasyScreen™ Gastrointestinal Parasite Detection Kit EP005-HT

GUDID 09351179001161

The EasyScreen™ Gastrointestinal Parasite Detection Kit is intended for use as an aid in the diagnosis of gastrointestinal illness by qualitative detection of Gastrointestinal Parasites from stool of patients with diarrhoea.

GENETIC SIGNATURES LIMITED

Multiple faecal parasite nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 09351179001161
• NIH Device Record Key: 765c6820-4711-413d-bb34-8f7f9180b620
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyScreen™ Gastrointestinal Parasite Detection Kit
• Version Model Number: 1
• Catalog Number: EP005-HT
• Company DUNS: 741249601
• Company Name: GENETIC SIGNATURES LIMITED
• 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: 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
• 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 -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351179001161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232672

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: 2024-06-26
• Device Publish Date: 2024-06-18

Devices Manufactured by GENETIC SIGNATURES LIMITED

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• 09351179000188 - EasyScreen™ Sample Processing Kit: 2024-06-26 The EasyScreen™ Sample Processing Kit (SP008B) is designed to rapidly isolate nucleic acids (DNA and RNA) from clinical sample
• 09351179001161 - EasyScreen™ Gastrointestinal Parasite Detection Kit: 2024-06-26The EasyScreen™ Gastrointestinal Parasite Detection Kit is intended for use as an aid in the diagnosis of gastrointestinal illness by qualitative detection of Gastrointestinal Parasites from stool of patients with diarrhoea.
• 09351179001161 - EasyScreen™ Gastrointestinal Parasite Detection Kit: 2024-06-26 The EasyScreen™ Gastrointestinal Parasite Detection Kit is intended for use as an aid in the diagnosis of gastrointestinal ill
• 09351179004070 - EasyScreen™ Gastrointestinal Parasite PCR Positive Control: 2024-06-26 The EasyScreen™ Gastrointestinal Parasite PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of