Xpert GBS LB

FDA registration

CEPHEID·2 products·🇺🇸 United States

410200 revogene GBS LB

FDA registration

MERIDIAN BIOSCIENCE, INC.·2 products·🇺🇸 United States

Simplexa™ GBS Direct

FDA registration

DiaSorin Molecular LLC·2 products·🇺🇸 United States

BD MAX PCR Cartridge

FDA registration

BECTON, DICKINSON & CO.·2 products·🇺🇸 United States

Xpert GBS LB

FDA registration

Cepheid·2 products·🇺🇸 United States

Revogene GBS LB

FDA registration

Meridian Bioscience Canada Inc.·2 products·🇨🇦 Canada

BD MAX PCR Cartridge

FDA registration

GeneOhm Sciences Canada, ULC.·2 products·🇨🇦 Canada

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System

FDA 510(k)

FDA Class 1 ·Microbiology

BD MAX GBS ASSAY, BD MAX INSTRUMENT

FDA 510(k)

FDA Class 1 ·Microbiology

HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB

FDA 510(k)

FDA Class 1 ·Microbiology

Simplexa GBS Direct, Simplexa GBS Positive Control Pack

FDA 510(k)

FDA Class 1 ·Microbiology

GenePOC GBS LB

FDA 510(k)

FDA Class 1 ·Microbiology

Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems

FDA 510(k)

FDA Class 1 ·Microbiology

ARIES GBS Assay

FDA 510(k)

FDA Class 1 ·Microbiology

Solana GBS Assay

FDA 510(k)

FDA Class 1 ·Microbiology

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B

FDA 510(k)

FDA Class 1 ·Microbiology

AMPLIVUE GBS ASSAY

FDA 510(k)

FDA Class 1 ·Microbiology

ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM

FDA 510(k)

FDA Class 1 ·Microbiology

XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)

FDA 510(k)

FDA Class 1 ·Microbiology

Portrait GBS Assay

FDA 510(k)

FDA Class 1 ·Microbiology