Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

NJR is the FDA product code for Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test, a class I device type, regulated under 21 CFR 866.3740. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 18 510(k) clearances under this code, the most recent dated 2023-09-27, and 11 recalls.