Product code
NJR: Nucleic acid amplification assay system, group b streptococcus, direct specimen test
FDA product code · Class I · Microbiology
Key facts
| Product code | NJR |
|---|---|
| Device | Nucleic acid amplification assay system, group b streptococcus, direct specimen test |
| Device class | Class I |
| Regulation number | 866.3740 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 10–99 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database