iC-Processor

GUDID B769ICPADAAA0000

The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.

ICUBATE, INC

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: B769ICPADAAA0000
• NIH Device Record Key: c107f2e1-8d10-48ba-97ea-fdacaa054e71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iC-Processor
• Version Model Number: iCP-ADAAA0000
• Company DUNS: 830140377
• Company Name: ICUBATE, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com
• Phone: 855-256-3330
• Email: support@icubate.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B769ICPADAAA0000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163390

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

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: 2019-07-18
• Device Publish Date: 2019-07-10

Devices Manufactured by ICUBATE, INC

• B769ICCAAQA00000 - iC-GN Assay: 2019-07-23 The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection
• B769ICCAAJA00000 - iC-GPC Assay: 2019-07-18 The iCubate, Inc. iC-GPC Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detectio
• B769ICPADAAA0000 - iC-Processor: 2019-07-18The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
• B769ICPADAAA0000 - iC-Processor: 2019-07-18 The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification
• B769ICRADAA00000 - iC-Reader: 2019-07-18 The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification