NJR

Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

Product code

NJR

Device name

Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

Device class

Class 1

21 CFR

21 CFR 866.3740

Medical specialty

Microbiology

Marketing pathway

510(K) Exempt

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

18 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-09-27.

1 summaries are archived here for direct download.