INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

FluChip-8G Influenza A+B Assay

FDA 510(k)

FDA Class 2 ·Microbiology

LEGIONELLA PNEUMOPHILA IGG/IGM

FDA 510(k)

FDA Class 2 ·Microbiology

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

TRU Legionella

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

FDA 510(k)

FDA Class 2 ·Microbiology

GenePOC Strep A

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX LEGIONELLA URINARY ANTIGEN EIA

FDA 510(k)

FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping

FDA 510(k)

FDA Class 2 ·Microbiology

QUICKVUE IN-LINE ONE-STEP STREP A TEST

FDA 510(k)

FDA Class 1 ·Microbiology

CARDS(TM) STREP A CATALOG NO. CR-7545

FDA 510(k)

FDA Class 1 ·Microbiology

MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)

FDA 510(k)

FDA Class 1 ·Microbiology

BBL STREP GROUPING KIT

FDA 510(k)

FDA Class 1 ·Microbiology

PHADIRECT STREP A TEST

FDA 510(k)

FDA Class 1 ·Microbiology

EZ DETECT, 5 MINUTE STREP-A COLOR TEST

FDA 510(k)

FDA Class 1 ·Microbiology

CLEARVIEW STREP A

FDA 510(k)

FDA Class 1 ·Microbiology

VENTRESCREEN STREP A TEST

FDA 510(k)

FDA Class 1 ·Microbiology

OXOID STREPTOCOCAL GROUPING KIT

FDA 510(k)

FDA Class 1 ·Microbiology

V-TREND STREP A TEST

FDA 510(k)

FDA Class 1 ·Microbiology

PHARMACIA STREP A DIRECT SWAB TEST

FDA 510(k)

FDA Class 1 ·Microbiology