MOCK PIE

Basic Information

• Brand Name: MOCK PIE
• Primary DI: 00628055344131
• Version / Model: 610208
• Catalog Number: 610208
• Company Name: Meridian Bioscience Canada Inc
• Labeler DUNS: 204006360
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-21
• Public Version: 3
• Public Version Date: 2021-11-08
• Public Version Status: Update
• Public Device Record Key: 88132f06-0a28-41c9-a701-74a1ea83cac5
• Distribution End Date: 2021-09-30

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62346	Centrifuge tube counterbalance	A device in the form of a centrifuge tube intended to balance weight across a centrifuge rotor when processing uneven numbers of tubes or tubes containing different volumes of fluid. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628055344131	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -30 – 50 Degrees Celsius