EasyScreen™ Gastrointestinal Parasite PCR Positive Control PC-PROT-001

GUDID 09351179004070

The EasyScreen™ Gastrointestinal Parasite PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the protozoan targets in the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). The Positive Control does not require processing and is designed to be added directly to the PCR mastermix when a positive signal in all detection channels is required for quality control purposes. This Positive Control demonstrates that all PCR targets are being detected as expected, and does not provide any results from clinical specimens. This Positive Control is for Investigational in vitro Diagnostic (IVD) Use Only in hospital and pathology laboratories or similar, by trained personnel.

GENETIC SIGNATURES LIMITED

Multiple-type gastrointestinal pathogen nucleic acid IVD, control

• Primary Device ID: 09351179004070
• NIH Device Record Key: 089bf7d6-34d6-4646-9535-2619499bd5bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyScreen™ Gastrointestinal Parasite PCR Positive Control
• Version Model Number: 1
• Catalog Number: PC-PROT-001
• 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	09351179004070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232672

FDA Product Code

• PCH: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay 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: 2024-06-26
• Device Publish Date: 2024-06-18

Devices Manufactured by GENETIC SIGNATURES LIMITED

• 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: 2024-06-26 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: 2024-06-26The EasyScreen™ Gastrointestinal Parasite PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the protozoan targets in the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). The Positive Control does not require processing and is designed to be added directly to the PCR mastermix when a positive signal in all detection channels is required for quality control purposes. This Positive Control demonstrates that all PCR targets are being detected as expected, and does not provide any results from clinical specimens. This Positive Control is for Investigational in vitro Diagnostic (IVD) Use Only in hospital and pathology laboratories or similar, by trained personnel.
• 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