Product code OWD
- Device name
- Somatic Gene Mutation Detection System
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
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| P170041S008 | Abbott RealTime IDH1 | Abbott Molecular, Inc. | 2026-03-20 |
| P170005S005 | Abbott RealTime IDH2 | Abbott Molecular, Inc. | 2026-03-20 |
| P200014S011 | cobas® EZH2 Mutation Test | Roche Molecular System, Inc. | 2026-03-17 |
| P140023S032 | cobas® KRAS Mutation Test | Roche Molecular Systems, Inc. | 2026-03-17 |
| P120019S043 | cobas® EGFR Mutation Test, v2.0 | Roche | 2026-03-17 |
| P110020S044 | cobas® BRAF V600 Mutation Test | Roche Molecular Systems, Inc. | 2026-03-17 |
| P200014S010 | cobas® EZH2 Mutation Test | Roche Molecular System, Inc. | 2025-12-31 |
| P140023S031 | cobas® KRAS Mutation Test | Roche Molecular Systems, Inc. | 2025-12-31 |
| P120019S042 | cobas® EGFR Mutation Test, v2.0 | Roche | 2025-12-31 |
| P110020S043 | cobsa® BRAF V600 Mutation Test | Roche Molecular Systems, Inc. | 2025-12-31 |
| P190001S002 | therascreen® PIK3CA RGQ PCR Kit | QIAGEN GmbH | 2025-10-22 |
| P180043S007 | QIAGEN therascreen® FGFR RGQ RT-PCR Kit | QIAGEN GmbH | 2025-10-03 |
| P120019S027 | cobas EGFR Mutation Test v2 | Roche | 2025-01-27 |
| P110027S018 | therascreen® KRAS RGQ PCR Kit | QIAGEN GmbH | 2025-01-16 |
| P180043S008 | therascreen FGFR RGQ PCR Kit | QIAGEN GmbH | 2024-12-06 |
| P180043S009 | therascreen FGFR RGQ RT-PCR Kit | QIAGEN GmbH | 2024-10-23 |
| P200014S009 | cobas® EZH2 Mutation Test | Roche Molecular System, Inc. | 2024-10-10 |
| P120019S040 | COBAS EGFR MUTATION TEST | Roche | 2024-10-10 |
| P160040S013 | LeukoStrat CDx FLT3 Mutation Assay | Invivoscribe Technologies, Inc. | 2024-09-27 |
| P110027S017 | therascreen® KRAS RGQ PCR Kit | QIAGEN GmbH | 2024-06-21 |
| P140023S030 | Roche cobas KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit | Roche Molecular Systems, Inc. | 2024-05-15 |
| P140023S029 | Roche cobas DNA Sample Preparation Kit | Roche Molecular Systems, Inc. | 2024-04-11 |
| P110020S042 | Roche cobas 4800 BRAF V600 Mutation Test | Roche Molecular Systems, Inc. | 2024-04-11 |
| P180043S006 | therascreen FGFR RGQ RT-PCR Kit | QIAGEN GmbH | 2023-12-22 |
| P200014S008 | Roche cobas® EZH2 Mutation Test | Roche Molecular System, Inc. | 2023-12-21 |
| P140023S028 | Roche cobas KRAS Mutation Test | Roche Molecular Systems, Inc. | 2023-12-21 |
| P120019S038 | Roche cobas EFGR Mutation Test, v2.0 | Roche | 2023-12-21 |
| P110020S041 | Roche cobas BRAF V600 Mutation Test | Roche Molecular Systems, Inc. | 2023-12-21 |
| P200014S007 | cobas® EZH2 Mutation Test | Roche Molecular System, Inc. | 2023-12-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
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| 04053228043560 | therascreen® FGFR RGQ RT-PCR Kit | QIAGEN GmbH | 2022-05-23 |
| 00054749005505 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-10-05 |
| 00875197005592 | cobas® EZH2 Mutation Test | Roche Molecular Systems, Inc. | 2020-08-01 |
| 00054749005161 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-07-01 |
| 00054749005529 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-07-01 |
| 00054749005222 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-07-01 |
| 00054749005215 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-07-01 |
| 00054749005208 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-07-01 |
| 00054749005192 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-07-01 |
| 00054749005185 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-07-01 |
| 00054749005178 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-07-01 |
| 00054749005154 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-07-01 |
| 00054749005147 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-07-01 |
| 00054749005123 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-07-01 |
| 04053228035725 | therascreen® BRAF RGQ PCR Kit | QIAGEN GmbH | 2020-06-11 |
| 00850052003739 | LeukoStrat | INVIVOSCRIBE, INC. | 2020-06-08 |
| 00850052003685 | LeukoStrat | INVIVOSCRIBE, INC. | 2020-05-29 |
| 00054749005512 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-05-01 |
| 00054749005093 | i-STAT | ABBOTT POINT OF CARE INC. | 2019-12-20 |
| 04053228034223 | therascreen® PIK3CA RGQ PCR Kit | QIAGEN GmbH | 2019-06-05 |
| 04053228034094 | therascreen® FGFR RGQ RT-PCR Kit | QIAGEN GmbH | 2019-04-29 |
| 03573026559823 | THxID™ BRAF | BIOMERIEUX SA | 2017-05-12 |
| 04053228002048 | therascreen® KRAS RGQ PCR Kit | QIAGEN GmbH | 2017-01-04 |
| 04053228002062 | therascreen® EGFR RGQ PCR Kit | QIAGEN GmbH | 2017-01-04 |
| 00875197004199 | cobas® KRAS Mutation Test | Roche Molecular Systems, Inc. | 2015-07-30 |
| 03573026354909 | THxID™-BRAF | BIOMERIEUX SA | 2014-09-23 |
| 00875197004120 | cobas® DNA Sample Preparation Kit | Roche Molecular Systems, Inc. | 2014-09-10 |
| 00875197004137 | cobas® 4800 BRAF V600 Mutation Test | Roche Molecular Systems, Inc. | 2014-09-10 |