Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
NJR · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3740
Classification
FDA Product Code
NJR
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 866.3740
Review panel
MI
Medical specialty
Microbiology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.