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.
List of Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test devices (product code NJR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →