BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Immunology

LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP

FDA 510(k)

FDA Class 2 ·Microbiology

DISPENS-O-DISC MEROPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

SYSTEM U3

FDA 510(k)

FDA Class 2 ·Microbiology

HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Xpress CoV-2/Flu/RSV plus

FDA 510(k)

FDA Class 2 ·Microbiology

Revogene

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SAS SALMONELLA H POLY A-Z ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

TRU LEGIONELLA

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SHIGELLA SONNEI GROUP D ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 GRAM POSITIVE DOXCYCLINE

FDA 510(k)

FDA Class 2 ·Microbiology

MALDI Biotyper CA System

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SALMONELLA VI ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

MONOLISA ANTI-HAV IGM EIA

FDA 510(k)

FDA Class 2 ·Microbiology

SYSTEM U3 FOR NORFLOXACIN

FDA 510(k)

FDA Class 2 ·Microbiology