Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
- US Product Code (FDA)
- NJRView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 866.3740View CFR Regulation →
- Medical specialty
- Microbiology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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.
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Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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