VITEK 2 GRAM POSITIVE MEROPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4

FDA 510(k)

FDA Class 2 ·Immunology

OCEAN SCIENTIFIC VDRL TEST

FDA 510(k)

FDA Class 2 ·Microbiology

SS-DNA EIA DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Immunology

RF MICROASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT TOTAL ANTI-CARDIOLIPIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

ZORBA(TM) IGG REMOVAL REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTATTMII ANTI-DSDNA

FDA 510(k)

FDA Class 2 ·Immunology

GEN-PROBE APTIMA COMBO 2 ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO

FDA 510(k)

FDA Class 2 ·Immunology

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

IFA SENSIBAC CINOXACIN

FDA 510(k)

FDA Class 2 ·Microbiology

RELISA ENA ANTIBODY SCREENING TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK

FDA 510(k)

FDA Class 2 ·Immunology

K/K (ASMA/ANA) UNIVERSAL BIOPAK

FDA 510(k)

FDA Class 2 ·Immunology

LIAISON PLEX Gram-Negative Blood Culture Assay

FDA 510(k)

FDA Class 2 ·Microbiology

RRT TOTAL IGE TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology