Primary Device ID | B769ICCAAJA00000 |
NIH Device Record Key | 2837d152-0435-4f06-b329-1e5481bb21c4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | iC-GPC Assay |
Version Model Number | iCC-AAJA00000 |
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 |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com | |
Phone | 855-256-3330 |
support@icubate.com |
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 |
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 |
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 |
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 Issuing Agency | Device ID |
---|---|
HIBCC | B769ICCAAJA00000 [Primary] |
PAM | Gram-Positive Bacteria And Their Resistance Markers |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-07-18 |
Device Publish Date | 2019-07-10 |
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 | 2019-07-18The 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. |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IC-GPC ASSAY 87305290 not registered Live/Pending |
iCubate, Inc. 2017-01-18 |