iC-Processor
GUDID B769ICPADAAA0000
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 Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory| Primary Device ID | B769ICPADAAA0000 |
| NIH Device Record Key | c107f2e1-8d10-48ba-97ea-fdacaa054e71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iC-Processor |
| Version Model Number | iCP-ADAAA0000 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B769ICPADAAA0000 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163390
FDA Product Code
| NSU | Instrumentation For Clinical Multiplex Test Systems |
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 | 2019-07-18 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 | 2019-07-18The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets. |
| 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-Processor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IC-PROCESSOR 97499658 not registered Live/Pending |
iCubate, Inc. 2022-07-12 |
 IC-PROCESSOR 85609499 not registered Live/Pending |
iCubate, Inc. 2012-04-26 |
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