PMA P110027S004
- Device
- QIAGEN THERASCREEN KRAS RGQ PCR KIT
- Applicant
- QIAGEN GmbH
- PMA number
- P110027
- Supplement
- S004
- Product code
- OWD
- Decision date
- 2015-02-13
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- NEW ASSEMBLY LINE FOR MANUFACTURING (ASSEMBLING) QIAAMP MINELUTE SPIN COLUMNS USED TO ISOLATE AND PURIFY DNA.
Current openFDA PMA Record#
- Device
- QIAGEN THERASCREEN KRAS RGQ PCR KIT
- Applicant
- QIAGEN GmbH
- PMA number
- P110027
- Supplement
- S004
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2015-02-13
- Decision code
- OK30
- Date received
- 2015-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- NEW ASSEMBLY LINE FOR MANUFACTURING (ASSEMBLING) QIAAMP MINELUTE SPIN COLUMNS USED TO ISOLATE AND PURIFY DNA.