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)
Top companies in OWD
| Company | 510(k)s | Recalls |
|---|---|---|
| Qiagen Sciences LLC | 0 | 6 |
| Roche Molecular Systems, Inc. | 0 | 6 |
| Qiagen GmbH | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2023 | Qiagen 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 |
OWD | None listed |
| Jul 20, 2022 | Qiagen Sciences LLC FGFR RGQ RT-PCR Kit (RUO, not IVD)
REF 8747010 Open, Classified |
OWD | None listed |
| Jul 20, 2022 | Qiagen Sciences LLC therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US)
REF 874711 Open, Classified |
OWD | None listed |
| Jul 20, 2022 | Qiagen Sciences LLC therascreen FGFR RGQ RT-PCR kit (US IVD)
REF 874721 Open, Classified |
OWD | None listed |
| Feb 25, 2022 | Qiagen Sciences LLC therascreen KRAS RGQ PCR Kit (24)
REF 874052 (Japan IVD, not released in the USA) Open, Classified |
OWD | None listed |
| Feb 25, 2022 | Qiagen Sciences LLC therascreen KRAS RGQ PCR Kit (24)
Model Number(s): REF 870021 (US IVD) Open, Classified |
OWD | None listed |
| Sep 3, 2021 | Roche Molecular Systems, Inc. cobas EGFR Mutation Test v2-Somatic gene mutation detection system
Catalog Number :07248563190 Open, Classified |
OWD | None listed |
| Dec 11, 2020 | Qiagen 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 |
OWD | None listed |
| Apr 5, 2016 | Roche 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 |
OWD | None listed |
| Mar 15, 2016 | Roche Molecular Systems, Inc. cobas EGFR Mutation Test, v2 and cobas cfDNA Sample
Preparation Hungarian Translation Instructions for Use Terminated |
OWD | None listed |
| Jun 26, 2015 | Roche 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 |
OWD | None listed |
| Mar 25, 2015 | Roche Molecular Systems, Inc. cobas EGFR Mutation Test
epidermal growth factor receptor (EGFR) gene DNA assay Terminated |
OWD | None listed |
| Nov 2, 2012 | Roche 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 |
OWD | None listed |
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