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 Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance Centrifuge tube counterbalance 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