Product code NJR— Microbiology
AMPLIVUE GBS ASSAY
- Advisory panel
- Microbiology
- Total cleared
- 18
Recent clearances under product code NJR
- K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
- K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
- K182467 — Simplexa GBS Direct, Simplexa GBS Positive Control Pack
- K181156 — Panther Fusion GBS Assay
- K173725 — NeuMoDx GBS Assay
- K173250 — Solana GBS Assay
- K170557 — GenePOC GBS LB
- K162772 — ARIES GBS Assay
- K143312 — Portrait GBS Assay
- K133503 — AMPLIVUE GBS ASSAY
- K121539 — XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
- K121044 — ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
- K111860 — BD MAX GBS ASSAY, BD MAX INSTRUMENT
- K112125 — ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
- K090191 — HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB
- K062948 — SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
- K060540 — XPERT, GENEXPERT DX SYSTEM
- K022504 — IDI-STREP B ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.