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- Gastroenterology and UrologyReview Panel
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- MiscellaneousMiscellaneous
- OYMProstrate Cancer Genes Nucleic Acid Amplification Test System3Product Code
- KTJSystem, Test, Alpha-Fetoprotein, Ria3Product Code
- LOKKit, Test, Alpha-Fetoprotein For Neural Tube Defects3Product Code
- LTQCalibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum3Product Code
- MANAssay, Interleukin3Product Code
- MJBAntigen, Cancer 5493Product Code
- MTFTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer3Product Code
- MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions3Product Code
- MYZKit, Test (Donors), For Bloodborne Pathogen2Product Code
- MZATest, Equipment, Automated Bloodborne PathogenNProduct Code
- MZETest, Donor, Cmv2Product Code
- MZFTest, Hiv Detection3Product Code
- MZLKit, Test, Quality Control For EndotoxinNProduct Code
- NAFAntigen(Complexed),Prostate Specific,(Cpsa)3Product Code
- NAHSystem, Test, Tumor Marker, For Detection Of Bladder Cancer3Product Code
- NYQChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer3Product Code
- OAWCancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic MesotheliomaFProduct Code
- OCBRt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection3Product Code
- OTRResearch Use Only/Immunology DevicesNProduct Code
- OWDSomatic Gene Mutation Detection System3Product Code
- P220005CRCDx RAS Mutation Detection Assay KitAPPRPMA Approval
- P210002therascreen PDGFRA RGQ PCR KitAPPRPMA Approval
- P200014cobas® EZH2 Mutation TestAPPRPMA Approval
- P190026therascreen BRAF V600E RGQ PCR KitAPPRPMA Approval
- P190004therascreen PIK3CA RGQ PCR KitAPPRPMA Approval
- P190001therascreen PIK3CA RGQ PCR KitAPPRPMA Approval
- P180043therascreen FGFR RGQ RT-PCR KitAPPRPMA Approval
- P170041Abbott RealTime IDH1APPRPMA Approval
- P170005Abbott RealTime IDH2APPRPMA Approval
- P160040LeukoStrat CDx FLT3 Mutation AssayAPPRPMA Approval
- P120014THxID-BRAF kit3PMA Approval
- P170005Abbott RealTime IDH23PMA Approval
- P170041Abbott RealTime IDH13PMA Approval
- P170005Abbott RealTime IDH23PMA Approval
- P170041Abbott RealTime IDH13PMA Approval
- P120019cobas EGFR Mutation Test v23PMA Approval
- P110020cobas BRAF V600 Mutation Test3PMA Approval
- P200014cobas® EZH2 Mutation Test3PMA Approval
- P120019cobas EGFR Mutation Test and cobas EGFR Mutation Test v23PMA Approval
- P140023cobas KRAS Mutation Test3PMA Approval
- P180043therascreen FGFR RGQ RT-PCR Kit3PMA Approval
- P200014cobas® EZH2 Mutation Test3PMA Approval
- P140023cobas KRAS Mutation Test3PMA Approval
- P160040LeukoStrat CDx FLT3 Mutation Assay3PMA Approval
- P190026therascreen BRAF V600E RGQ PCR Kit3PMA Approval
- P190001therascreen PIK3CA RGQ PCR Kit3PMA Approval
- P180043therascreen FGFR RGQ PCR Kit3PMA Approval
- P120022therascreen EGFR RGQ PCR Kit3PMA Approval
- P110027therascreen KRAS RGQ PCR Kit3PMA Approval
- P120014THxID-BRAF assay kit3PMA Approval
- P170041Abbott RealTime IDH1 Assay3PMA Approval
- P140023cobas KRAS Mutation Test3PMA Approval
- P110020cobas BRAF V600 Mutation Test3PMA Approval
- P120019cobas EGFR Mutation Test and cobas EGFR Mutation Test v23PMA Approval
- P120022therascreen EGFR RGQ PCR Kit3PMA Approval
- P120019cobas EGFR Mutation Test v23PMA Approval
- P110020cobas 4800 BRAF V600 Mutation Test3PMA Approval
- P170041RealTime IDH13PMA Approval
- P170005RealTime IDH23PMA Approval
- P120014THxID BRAF assay kit3PMA Approval
- P190004therascreen PIK3CA RGQ PCR Kit3PMA Approval
- P190001therascreen PIK3CA RGQ PCR Kit3PMA Approval
- P120019COBAS EGFR Mutation Test and cobas EGFR Mutation Test, v2.03PMA Approval
- P140023cobas KRAS Mutation Test3PMA Approval
- P110020cobas BRAF v600 Muttaion Test3PMA Approval
- P180043therascreen FGFR RGQ RT-PCR Kit3PMA Approval
- P160040LeukoStrat CDx FLT3 Mutation Assay3PMA Approval
- P110020cobas BRAF V600 Mutation Test3PMA Approval
- P140023cobas KRAS Mutation Test3PMA Approval
- P120019cobas EGFR Mutation Test and cobas EGFR Mutation Test v23PMA Approval
- P120019cobas EGFR Mutation Test and cobas EGFR Mutation Test v23PMA Approval
- P110020cobas BRAF V600 Mutation Test3PMA Approval
- P140023cobas KRAS Mutation Test3PMA Approval
- P160040LeukoStrat CDx FLT3 Mutation Assay3PMA Approval
- P160040LeukoStrat CDx FLT3 Mutation Assay3PMA Approval
- P120022therascreen EGFR RGQ PCR Kit3PMA Approval
- P120019cobas EGFR Mutation Test and cobas EGFR Mutation Test v23PMA Approval
- P110020cobas BRAF V600 Mutation Test3PMA Approval
- P140023cobas KRAS Mutation Test3PMA Approval
- P120019Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit3PMA Approval
- P110020cobas BRAF V600 Mutation Test3PMA Approval
- P140023cobas KRAS Mutation Test3PMA Approval
- P120019cobas EGFR Mutation Test and cobas EGFR Mutation Test v23PMA Approval
- P110020Cobas BRAF V600 Mutation Test3PMA Approval
- P170041Abbott RealTime IDH13PMA Approval
- P110020cobas BRAF V600 Mutation Test3PMA Approval
- P120019cobas EGFR Mutation Test, V2.03PMA Approval
- P140023cobas KRAS Mutation Test3PMA Approval
- P120019Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit3PMA Approval
- P140023Roche cobas KRAS Mutation Test, Roche cobas DNA Sample Preparation Kit3PMA Approval
- P110020Roche cobas DNA Sample Preparation Kit, Roche cobas 4800 BRAF V600 Mutation Test3PMA Approval
- P120014THxID BRAF assay kit3PMA Approval
- P120019cobas EGFR Mutation Test v23PMA Approval
- P120019cobas EGFR Mutation Test v23PMA Approval
- P120022therascreen EGFR RGQ PCR Kit3PMA Approval
- P110027therascreen KRAS RGQ PCR Kit3PMA Approval
- P120019Cobas EGFR Mutation Test and Cobas EGFR Mutation Test v23PMA Approval
- P110020Cobas 4800 BRAF V600 Mutation Test3PMA Approval
- P140023Cobas KRAS Mutation Test3PMA Approval
- P120022therascreen EGFR RGQ PCR kit3PMA Approval
- P160040LeukoStrat CDx FLT3 Mutation Assay3PMA Approval
- P120022Therascreen EGFR RGQ PCR Kit3PMA Approval
- P120019Cobas EGFR Mutation Test and Cobas EGFR v2 Mutation Test3PMA Approval
- P110020Cobas 4800 BRAF V600 Mutation Test3PMA Approval
- P140023Cobas KRAS Mutation Test3PMA Approval
- P140023Roche cobas KRAS Mutation Test /Roche cobas DNA Sample Preparation Kit3PMA Approval
- P110020Roche cobas DNA Sample Preparation Kit / Roche cobas 4800 BRAF V600 Mutation Test3PMA Approval
- P120019Roche cobas EGFR Mutation Test / Roche cobas DNA Sample Preparation Kit3PMA Approval
- P120019cobas EGFR Mutation Test v23PMA Approval
- P110020cobas 4800 BRAF V600 Mutation Test3PMA Approval
- P140023cobas KRAS Mutation Test3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P110020cobas BRAF V600 Mutation Test3PMA Approval
- P120019cobas EGFR Mutation Test and cobas EGFR Mutation Test v23PMA Approval
- P140023cobas KRAS Mutation Test3PMA Approval
- P170005Abbott RealTime IDH23PMA Approval
- P120022Therascreen EGFR, RGQ, PCR Kit3PMA Approval
- P120022THERASCREEN EGFR RGQ PCR KIT3PMA Approval
- P160040LeukoStrat CDx FLT3 Mutation Assay3PMA Approval
- P120014THxID-BRAF kit3PMA Approval
- P110020Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P140023COBAS KRAS MUTATION TEST3PMA Approval
- P150047Cobas EGFR MUTATION TEST v23PMA Approval
- P120019cobas EGFR Mutation Test and cobas® EGFR Mutation Test, v23PMA Approval
- P150044cobas EGFR MUTATION TEST v23PMA Approval
- P140023COBAS KRAS MUTATION TEST3PMA Approval
- P120019COBAS EGFR MUTATION TEST3PMA Approval
- P150047COBAS EGFR MUTATION TEST3PMA Approval
- P140023COBAS KRAS MUTATION TEST3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P120022THERASCREEN EGFR RGQ PCR KIT3PMA Approval
- P120019COBAS EGFR MUTATION TEST3PMA Approval
- P140023COBAS KRAS MUTATION TEST3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P150047cobas EGFR MUTATION TEST v23PMA Approval
- P140023COBAS KRAS MUTATION TEST3PMA Approval
- P120019COBAS EGFR MUTATION TEST3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P140023COBAS KRAS MUTATION TEST3PMA Approval
- P120014THXID-BRAF KIT3PMA Approval
- P120019COBAS EGFR MUTATION TEST V23PMA Approval
- P120022THERASCREEN EGFR RGQ PCR KIT3PMA Approval
- P110027THERASCREEN KRAS RGQ PCR KIT3PMA Approval
- P140023ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT3PMA Approval
- P120022THERASCREEN EGFR RGQ PCR KIT3PMA Approval
- P110027THERASCREEN KRAS RGQ PCR KIT3PMA Approval
- P120019ROCHE COBAS EGFR MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT3PMA Approval
- P110020ROCHE COBAS DNA SAMPLE PREPARATION KIT, ROCHE COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P140023ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT3PMA Approval
- P120022THERASCEEN EGFR RGQ PCR KIT3PMA Approval
- P120014THXID BRAF KIT3PMA Approval
- P120014THXID BRAF KIT3PMA Approval
- P140023COBAS KRAS MUTATION TEST3PMA Approval
- P110027QIAGEN THERASCREEN KRAS RGQ PCR KIT3PMA Approval
- P120022QIAGEN THERASCREEN EGFR RGQ PCR KIT3PMA Approval
- P110027QIAGEN THERASCREEN KRAS RGQ PCR KIT3PMA Approval
- P120022QIAGEN THERASCREEN EGFR RGQ PCR KIT3PMA Approval
- P120019COBAS EGFR MUTATION TEST3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P120014THXID BRAF KIT3PMA Approval
- P120022THERASCREEN EGFR RGQ PCR KIT3PMA Approval
- P110027THERASCREEN KRAS RGQ PCR KIT3PMA Approval
- P110027QIAGEN THERASCREEN KRAS RGQ PCR KIT3PMA Approval
- P120022QIAGEN THERASCREEN EGFR RGQ PCR KIT3PMA Approval
- P120014THXID-BRAF KIT3PMA Approval
- P120022THERASCREEN EGFR RGQ PCR KIT3PMA Approval
- P110027THERASCREEN KRAS RGQ PCR KIT3PMA Approval
- P120019COBAS EGFR MUTATION TEST3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P120022THERASCREEN EGFR RGQ PCR KIT3PMA Approval
- P110027THERASCREEN KRAS RGQ PCR KIT3PMA Approval
- P120014THXID BRAF KIT3PMA Approval
- P120022THERASCREEN EGFR RGQ PCR KIT3PMA Approval
- P110027THERASCREEN KRAS RGQ PCR KIT3PMA Approval
- P120019COBAS EGFR MUTATION TEST3PMA Approval
- P110020COBAS BRAF V600 MUTATION TEST3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P120019COBAS EGFR MUTATION TEST3PMA Approval
- P120019COBAS EGFR MUTATION TEST3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P120019COBAS EGFR MUTATION TEST3PMA Approval
- P120022THERASCREEN EGFR RGQ PCR KIT3PMA Approval
- P120014BIOMERIEUX THXID BRAF ASSAY KIT3PMA Approval
- P120019COBAS EGFR MUTATION TEST3PMA Approval
- P110020ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 059855791903PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P110030THERASCREEN KRAS RGQ PCR KIT3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P110020ROCHE COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- P110020COBAS 4800 BRAF V600 MUTATION TEST3PMA Approval
- OYAP2psa3Product Code
- OYYLeukemia Translocation Panel Multiplex TestNProduct Code
- PILTest For Periprosthetic Joint InfectionNProduct Code
- QLCInterleukin 6NProduct Code
- QRFMulti-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer3Product Code
- QSEAlzheimer’S Disease Pathology Assessment Test2Product Code
- QWQAssays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors3Product Code
- SADJapanese Encephalitis Virus Immunological/Serology TestNProduct Code
- SETImmunoassay Blood Test For Amyloid Pathology Assessment2Product Code
- SFCNeurologic Disease Risk Assessment Molecular Test2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
cobas KRAS Mutation Test
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Roche Molecular Systems, Inc.
- Trade Name
- COBAS KRAS MUTATION TEST
- Generic Name
- Somatic gene mutation detection system
- Decision Date
- 5/7/2015
- Days to Decision
- 196 days
- Decision Code
- APPR
- FDA Decision
- Approval