OAI · Class II · 21 CFR 866.3225

FDA Product Code OAI: Assay, Enterovirus Nucleic Acid

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.

Leading manufacturers include Cepheid and bioMerieux, Inc..

2
Total
1
Cleared
303d
Avg days
2007
Since

FDA 510(k) Cleared Assay, Enterovirus Nucleic Acid Devices (Product Code OAI)

2 devices
1–2 of 2
Cleared Jun 23, 2008
NUCLISENS EASYQ ENTEROVIRUS SYSTEM
K063261
bioMerieux, Inc.
Microbiology · 602d
Not Cleared Mar 16, 2007
XPERT EV, MODEL GXEV-100N-10
DEN070004
Cepheid
Microbiology · 4d

About Product Code OAI - Regulatory Context