FDA Product Code NJR: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Group B Streptococci From Pre-partum And Intra-partum Women To Establish Colonization Status.
Leading manufacturers include Cepheid.
FDA 510(k) Cleared Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Devices (Product Code NJR)
About Product Code NJR - Regulatory Context
510(k) Submission Activity
18 total 510(k) submissions under product code NJR since 2002, with 18 receiving FDA clearance (average review time: 171 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
NJR devices are reviewed by the Microbiology panel. Browse all Microbiology devices →