PMA P160038S004
- Device
- Praxis Extended RAS Panel
- Applicant
- Illumina, Inc.
- PMA number
- P160038
- Supplement
- S004
- Product code
- PQP
- Decision date
- 2018-06-25
- Classification
- Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Redesign of Quality Control method that tests for cross-contamination and purity of Index Adapters which will include the obsolescence of Illumina’s Genome Analyzer IIx.
Current openFDA PMA Record#
- Device
- Praxis Extended RAS Panel
- Applicant
- Illumina, Inc.
- PMA number
- P160038
- Supplement
- S004
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2018-06-25
- Decision code
- OK30
- Date received
- 2018-06-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Redesign of Quality Control method that tests for cross-contamination and purity of Index Adapters which will include the obsolescence of Illumina’s Genome Analyzer IIx.