BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

ARTUS C. DIFFICILE QS-RGQ MDX KIT

FDA 510(k)

FDA Class 2 ·Microbiology

ZEUS ELISA HSV GC-I IGG TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)

FDA 510(k)

FDA Class 2 ·Microbiology

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

Panther Fusion GBS Assay

FDA 510(k)

FDA Class 1 ·Microbiology

ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT

FDA 510(k)

FDA Class 1 ·Microbiology

NeuMoDx GBS Assay

FDA 510(k)

FDA Class 1 ·Microbiology