Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Medical specialty
Microbiology
Device class
1
Regulation number
866.3740
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.