iC-GPC Assay
GUDID B769ICCAAJA00000
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.
ICUBATE, INC
Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry| 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 |
Customer Support Contacts
| 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 |
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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B769ICCAAJA00000 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163390
FDA Product Code
| PAM | Gram-Positive Bacteria And Their 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 | 2019-07-18 |
| 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 | 2019-07-18The 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 |
Trademark Results [iC-GPC Assay]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IC-GPC ASSAY 87305290 not registered Live/Pending |
iCubate, Inc. 2017-01-18 |
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