ClearanceBrief
Product code OWD ยท Class 3

Somatic Gene Mutation Detection System

0510(k)s in 12 months (0 all time)
0recalls in 12 months (13 all time)
0recalls that name a 510(k)
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Top companies in OWD

DateFirm and productCodeLinked 510(k)
Sep 29, 2023Qiagen GmbH
therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
Open, Classified
OWDNone listed
Jul 20, 2022Qiagen Sciences LLC
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
Open, Classified
OWDNone listed
Jul 20, 2022Qiagen Sciences LLC
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
Open, Classified
OWDNone listed
Jul 20, 2022Qiagen Sciences LLC
therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
Open, Classified
OWDNone listed
Feb 25, 2022Qiagen Sciences LLC
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
Open, Classified
OWDNone listed
Feb 25, 2022Qiagen Sciences LLC
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Open, Classified
OWDNone listed
Sep 3, 2021Roche Molecular Systems, Inc.
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Open, Classified
OWDNone listed
Dec 11, 2020Qiagen Sciences LLC
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected r
Terminated
OWDNone listed
Apr 5, 2016Roche Molecular Systems, Inc.
cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test f
Terminated
OWDNone listed
Mar 15, 2016Roche Molecular Systems, Inc.
cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation Instructions for Use
Terminated
OWDNone listed
Jun 26, 2015Roche Molecular Systems, Inc.
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-e
Terminated
OWDNone listed
Mar 25, 2015Roche Molecular Systems, Inc.
cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Terminated
OWDNone listed
Nov 2, 2012Roche Molecular Systems, Inc.
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V6
Terminated
OWDNone listed

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