QIAGEN THERASCREEN EGFR RGQ PCR KIT
FDA premarket approval P120022/S009 · decided 2015-04-24
Approval details
- PMA number
- P120022
- Supplement
- S009
- Supplement type
- Real-Time Process
- Trade name
- QIAGEN THERASCREEN EGFR RGQ PCR KIT
- Generic name
- Somatic gene mutation detection system
- Applicant
- QIAGEN GmbH
- Date received
- 2015-01-26
- Decision date
- 2015-04-24
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hilden
- Statement
- APPROVAL FOR REPLACEMENT OF THE RAW MATERIALS USED IN MANUFACTURING OF PRIMARY PACKAGING (BOTTLES AND CAPS) FOR BUFFERS IN THE QIAAMP DSP DNA FFPE TISSUE KIT.
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