DeviceClearance

Product code NJR— Microbiology

AMPLIVUE GBS ASSAY

Classification name
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device class
Class 1
Regulation
21 CFR 866.3740
Advisory panel
Microbiology
Total cleared
18
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NJR under 21 CFR 866.3740, via openFDA

Market context for product code NJR

FDA has cleared 18 devices under product code NJR between 2002 and 2023, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code NJR

Recent clearances under product code NJR

Data sourced from openFDA. This site is unofficial and independent of the FDA.