icubate.comIC-GN IC-Cassette For Use On The IC-System
ICubate, Inc.
ICUBATE, INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009506385 | 3009506385 | ICUBATE, INC | 1 | N | 2020-04-25 | 601 GENOME WAY STE 3005 Huntsville AL US 35806 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B769ICCAAJA00000 | iC-GPC Assay - The iCubate, Inc. iC-GPC Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram positive bacteria, which may cause bloodstream infection (BSI). The iC-GPC Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram positive cocci. | 855-256-3330 | support@icubate.com |
| B769ICCAAQA00000 | iC-GN Assay - 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. | 855-256-3330 | support@icubate.com |
| B769ICPADAAA0000 | iC-Processor - The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets. | 855-256-3330 | support@icubate.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 213131 | 1655227884 | K190341 | iC-GN iC-Cassette for use on the iC-System | PEN | 2019-06-28 |
| 213131 | 1182881478 | K163390 | iC-GPC Assay TM for use on the iC-SystemTM | PAM | 2017-08-08 |
Product Codes Associated With Registrations#
PMN#
IC-GPC Assay TM For Use On The IC-SystemTM
ICubate, Inc
GUDID#
iC-Reader - The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
2019-07-10
iC-Processor - The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
2019-07-10
iC-GPC Assay - The iCubate, Inc. iC-GPC Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram positive bacteria, which may cause bloodstream infection (BSI). The iC-GPC Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram positive cocci.
2019-07-10
iC-GN Assay - 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.
2019-07-15