K063261 is an FDA 510(k) clearance for the NUCLISENS EASYQ ENTEROVIRUS SYSTEM. This device is classified as a Assay, Enterovirus Nucleic Acid (Class II - Special Controls, product code OAI).
Submitted by bioMerieux, Inc. (Durham, US). The FDA issued a Cleared decision on June 23, 2008, 602 days after receiving the submission on October 30, 2006.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3225. 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..
| 510(k) Number | K063261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2006 |
| Decision Date | June 23, 2008 |
| Days to Decision | 602 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OAI — Assay, Enterovirus Nucleic Acid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3225 |
| Definition | 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. |