iC-Reader

GUDID B769ICRADAA00000

The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.

ICUBATE, INC

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated
Primary Device IDB769ICRADAA00000
NIH Device Record Key4bc15704-ff9a-42e4-9fc5-b1b3eca02248
Commercial Distribution StatusIn Commercial Distribution
Brand NameiC-Reader
Version Model NumberiCR-ADAA00000
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB769ICRADAA00000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NSUInstrumentation For Clinical Multiplex Test Systems

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 Assay2019-07-18 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-Reader2019-07-18The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
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-Reader]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IC-READER
IC-READER
97499669 not registered Live/Pending
iCubate, Inc.
2022-07-12
IC-READER
IC-READER
87301643 not registered Live/Pending
iCubate, Inc.
2017-01-13
IC-READER
IC-READER
85609489 not registered Dead/Abandoned
iCubate, Inc.
2012-04-26
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