Idylla™ MSI Test

GUDID 15415219000758

The 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.

Biocartis NV

Microsatellite instability IVD, kit, nucleic acid technique (NAT)
Primary Device ID15415219000758
NIH Device Record Key63928393-c368-4a96-a344-1dfedde40b5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameIdylla™ MSI Test
Version Model Number2
Company DUNS400686169
Company NameBiocartis NV
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105415219000751 [Unit of Use]
GS115415219000758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZJLynch Syndrome Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-11
Device Publish Date2023-05-03

Devices Manufactured by Biocartis NV

15415219000758 - Idylla™ MSI Test2023-05-11The 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 Test2023-05-11 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) Panel2018-11-23
05415219000119 - Idylla™ System2018-03-29 Up to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System.
05415219000126 - Idylla™ System2018-03-29 The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode reader placed directly below the touch

Trademark Results [Idylla]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IDYLLA
IDYLLA
85683500 not registered Dead/Abandoned
MATTEL, INC.
2012-07-21
IDYLLA
IDYLLA
79182950 5229898 Live/Registered
Biocartis
2015-09-04
IDYLLA
IDYLLA
79140962 4647124 Live/Registered
Biocartis N.V.
2013-10-07
IDYLLA
IDYLLA
79111284 4248136 Dead/Cancelled
COLIAN SPÓLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA
2012-02-29
IDYLLA
IDYLLA
78374004 3104797 Dead/Cancelled
MATTEL, INC.
2004-02-25

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