MOCK PIE 610208

GUDID 00628055344131

The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene® instrument and Revogene® assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower than eight in a run.

Meridian Bioscience Canada Inc

Centrifuge tube counterbalance

• Primary Device ID: 00628055344131
• NIH Device Record Key: 88132f06-0a28-41c9-a701-74a1ea83cac5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOCK PIE
• Version Model Number: 610208
• Catalog Number: 610208
• Company DUNS: 204006360
• Company Name: Meridian Bioscience Canada Inc
• 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: false
• 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

Customer Support Contacts

• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055344131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170558

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification 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: 2019-10-29
• Device Publish Date: 2019-10-21

Devices Manufactured by Meridian Bioscience Canada Inc

• 00628055344100 - Revogene®: 2019-11-11 The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assay
• 00628055344117 - Revogene® GBS LB: 2019-10-29 The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative in vitro diagnostic test designed to detect Gr
• 00628055344124 - Revogene® C. difficile: 2019-10-29 The Revogene® C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes a
• 00628055344131 - MOCK PIE: 2019-10-29The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene® instrument and Revogene® assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower than eight in a run.
• 00628055344131 - MOCK PIE: 2019-10-29 The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene® instrument and Revogene® assays. The MOCK P
• 00628055344162 - Revogene® Carba C: 2019-10-29 The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualitative in vitro diagnostic test designed for the
• 00628055344179 - Revogene® Strep A: 2019-10-29 The Revogene® Strep A assay, performed on the Revogene® instrument, is an automated, qualitative in vitro diagnostic test that