Primary Device ID | 15415219000758 |
NIH Device Record Key | 63928393-c368-4a96-a344-1dfedde40b5f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Idylla™ MSI Test |
Version Model Number | 2 |
Company DUNS | 400686169 |
Company Name | Biocartis NV |
Device Count | 6 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05415219000751 [Unit of Use] |
GS1 | 15415219000758 [Primary] |
PZJ | Lynch Syndrome Test System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-05-11 |
Device Publish Date | 2023-05-03 |
15415219000758 - Idylla™ MSI Test | 2023-05-11The Idylla MSI Test, for use on the Idylla System, uses formalin-fixed, paraffin embedded (FFPE) tissue sections of human CRC tumor, from which nucleic acids are liberated, then analyzed using PCR amplification of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) and subsequent melt-curve analysis. The Idylla MSI Test reports results as either microsatellite stable (MSS), or microsatellite instability high (MSI-H) or invalid. |
15415219000758 - Idylla™ MSI Test | 2023-05-11 The Idylla MSI Test, for use on the Idylla System, uses formalin-fixed, paraffin embedded (FFPE) tissue sections of human CRC tu |
15415219000635 - Idylla™ Respiratory (IFV-RSV) Panel | 2018-11-23 |
05415219000119 - Idylla™ System | 2018-03-29 Up to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System. |
05415219000126 - Idylla™ System | 2018-03-29 The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode reader placed directly below the touch |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IDYLLA 85683500 not registered Dead/Abandoned |
MATTEL, INC. 2012-07-21 |
IDYLLA 79182950 5229898 Live/Registered |
Biocartis 2015-09-04 |
IDYLLA 79140962 4647124 Live/Registered |
Biocartis N.V. 2013-10-07 |
IDYLLA 79111284 4248136 Dead/Cancelled |
COLIAN SPÃLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA 2012-02-29 |
IDYLLA 78374004 3104797 Dead/Cancelled |
MATTEL, INC. 2004-02-25 |