INTROL CF Panel I Control G106ac-1

GUDID 00852720008008

This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.

Mmqci

Cystic fibrosis IVD, control

• Primary Device ID: 00852720008008
• NIH Device Record Key: 5034854f-ef3a-4925-ba0b-41f8d1f8cafb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTROL CF Panel I Control
• Version Model Number: v.02
• Catalog Number: G106ac-1
• Company DUNS: 172874245
• Company Name: Mmqci
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 207-885-1072
• Email: info@mmqci.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852720008008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083171

FDA Product Code

• NZB: Quality Control Material, Genetics, Dna

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: 2019-12-13
• Device Publish Date: 2019-12-05

On-Brand Devices [INTROL CF Panel I Control]

• 00852720008008: This independent CF control is intended for in vitro diagnostic use to monitor the entire testin
• 00852720008015: This independent CF control is intended for in vitro diagnostic use to monitor the entire testin