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
Primary Device IDB769ICCAAJA00000
NIH Device Record Key2837d152-0435-4f06-b329-1e5481bb21c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameiC-GPC Assay
Version Model NumberiCC-AAJA00000
Company DUNS830140377
Company NameICUBATE, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com
Phone855-256-3330
Emailsupport@icubate.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB769ICCAAJA00000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PAMGram-Positive Bacteria And Their Resistance Markers

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-18
Device Publish Date2019-07-10

Devices Manufactured by ICUBATE, INC

B769ICCAAQA00000 - iC-GN Assay2019-07-23 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 Assay2019-07-18The 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 Assay2019-07-18 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-Processor2019-07-18 The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification
B769ICRADAA00000 - iC-Reader2019-07-18 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
IC-GPC ASSAY
87305290 not registered Live/Pending
iCubate, Inc.
2017-01-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.