Idylla™ MSI FFPE Reference Set SID-000114

GUDID 04260712780003

Idylla™ MSI FFPE Reference Set is intended as commutable, qualitative control material for microsatellite instability (MSI) markers in FFPE format based on human cell lines. It consists of MSI FFPE MSI-H control with all MSI markers at a frequency of 1x LOD for the Idylla™ MSI Test (refer to Idylla™ MSI Test package insert) and MSI FFPE MSS control with 0% frequency for all MSI markers. This Reference set enables monitoring of the performance, procedures and workflow of laboratory tests using FFPE in combination with the automatic workflow of the Idylla™ platform (Biocartis NV).

SensID GmbH

Exogenous DNA/RNA internal control IVD, kit
Primary Device ID04260712780003
NIH Device Record Keyd64c3e86-dd93-4287-814a-50beabbfddb8
Commercial Distribution StatusIn Commercial Distribution
Brand NameIdylla™ MSI FFPE Reference Set
Version Model NumberSID-000114
Catalog NumberSID-000114
Company DUNS313586371
Company NameSensID GmbH
Device Count1
DM Exempttrue
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

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
GS104260712780003 [Primary]

FDA Product Code

NZBQuality Control Material, Genetics, Dna

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-03
Device Publish Date2022-10-26

On-Brand Devices [Idylla™ MSI FFPE Reference Set]

04260712780003Idylla™ MSI FFPE Reference Set is intended as commutable, qualitative control material for mic
04260712780065Idylla™ MSI FFPE Reference Set is intended as commutable, qualitative control material for mic

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

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