iC-GN Assay

GUDID B769ICCAAQA00000

The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC-GN Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli.

ICUBATE, INC

Multiple bacterial bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple bloodstream bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple bloodstream bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple bloodstream bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: B769ICCAAQA00000
• NIH Device Record Key: ebc00bb2-ee17-4320-856c-ea0579735099
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iC-GN Assay
• Version Model Number: iCC-AAQA00000
• 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: true
• 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: 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B769ICCAAQA00000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190341

FDA Product Code

• PEN: Gram-Negative Bacteria And Associated Resistance Markers

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: 2019-07-23
• Device Publish Date: 2019-07-15

Devices Manufactured by ICUBATE, INC

• B769ICCAAQA00000 - iC-GN Assay: 2019-07-23The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC-GN Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli.
• 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: 2019-07-18 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