Therascreen EGFR, RGQ, PCR Kit
FDA premarket approval P120022/S015 · decided 2017-07-24
Approval details
- PMA number
- P120022
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Therascreen EGFR, RGQ, PCR Kit
- Generic name
- Somatic gene mutation detection system
- Applicant
- QIAGEN GmbH
- Date received
- 2017-06-29
- Decision date
- 2017-07-24
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hilden
- Statement
- Improvement to the therascreen EFGR Kit stock Internal Control (IC) Mix manufacturing process.
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|---|---|---|
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| QIAstat-Dx GI Panel 2 Mini B (K250324) | QIAGEN GmbH | 2025-02-28 |
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