510(k) K171511
K171511 is an FDA 510(k) premarket notification submitted by R-Biopharm AG for the device "RIDA GENE Norovirus GI/GII". The FDA issued a decision of Substantially Equivalent on August 21, 2017. The device falls under product code PIQ (Reagents For Detection Of Norovirus Nucleic Acid), a Class II device regulated under 21 CFR 866.3990. R-Biopharm AG has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 2017
- Date Received
- May 24, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagents For Detection Of Norovirus Nucleic Acid
- Device Class
- Class II
- Regulation Number
- 866.3990
- Review Panel
- MI
- Submission Type
Qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroup I and genogroup II from specimens e.g., stool collected from individuals with symptoms of acute gastroenteritis.