# Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 18
- **Registered establishments:** 13
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NJR)
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