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BIOCARTIS NV

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30099728733009972873BIOCARTIS NV1N2026-01-01Generaal De Wittelaan 11B Mechelen Antwerpen BE 2800

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2088441773337155P250005Idylla CDx MSI TestSFL2025-08-15
2088441803379048K211181Idylla MSI TestPZJ2023-02-27
2088441485146087K163628Idylla Respiratory (IFV-RSV) PanelOCC2017-08-30
2088441741950295
2088441929974056

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PZJ12023-02-27
OCC12017-08-30

PMN#

GUDID#

Idylla CDx MSI Test - For in vitro diagnostic use. For Prescription Use Only.For use on the Biocartis Idylla System only.The Idylla CDx MSI Test is an in vitro diagnostic test intended for the qualitative detection of a panel of sevenmonomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) for identification ofmicrosatellite instability (MSI) in colorectal cancer (CRC) tissue. The Idylla CDx MSI Test uses formalin-fixed,paraffin embedded (FFPE) tissue sections from patients with CRC, from which nucleic acids are extracted, thenanalyzed using PCR amplification and subsequent melt-curve analysis. The Idylla CDx MSI Test reports MSIstatus as either Microsatellite Stable (MSS) or Microsatellite Instability-High (MSI-H) or invalid.The test is intended as a companion diagnostic to identify CRC patients with MSI-H status, who may benefitfrom treatment with OPDIVO (nivolumab) as a monotherapy and/or treatment with OPDIVO (nivolumab) incombination with YERVOY (ipilimumab).

Biocartis NV

2025-11-01

Idylla™ MSI Test - 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

2023-05-03