MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSTREP PLUS PANEL, VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

HARDYDISK AST DORIPENEM 10 UG

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST Delafloxacin (DFX) (0.002-32 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE

FDA 510(k)

FDA Class 2 ·Microbiology

CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)

FDA 510(k)

FDA Class 2 ·Microbiology

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit

FDA 510(k)

FDA Class 2 ·Microbiology

STAINING SYSTEM FOR PNEUMOCYSTIS CARINII

FDA 510(k)

FDA Class 2 ·Microbiology

AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology

MUELLER HINTON AGAR W/OXACILLIN

FDA 510(k)

FDA Class 2 ·Microbiology

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SALMONELLA O GROUP T FACTOR 42 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96

FDA 510(k)

FDA Class 2 ·Microbiology

ADVIA Centaur Herpes-1 IgG

FDA 510(k)

FDA Class 2 ·Microbiology

DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL

FDA 510(k)

FDA Class 2 ·Microbiology

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

THE GOLDEN QUAD TEST (TOXO)

FDA 510(k)

FDA Class 2 ·Microbiology