510(k) K063261
K063261 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "NUCLISENS EASYQ ENTEROVIRUS SYSTEM". The FDA issued a decision of Substantially Equivalent on June 23, 2008. The device falls under product code OAI (Assay, Enterovirus Nucleic Acid), a Class II device regulated under 21 CFR 866.3225. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2008
- Date Received
- October 30, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Enterovirus Nucleic Acid
- Device Class
- Class II
- Regulation Number
- 866.3225
- Review Panel
- MI
- Submission Type
Consists of primers, probes, enzymes and controls for the amplification and detection of enterovirus RNA in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis. The detection of enterovirus RNA, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of viral meningitis caused by enterovirus.