CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST TETRACYCLINE

FDA 510(k)

FDA Class 2 ·Microbiology

CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD

FDA 510(k)

FDA Class 2 ·Microbiology

BUHLMANN fCAL ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System

FDA 510(k)

FDA Class 2 ·Microbiology

ORTHO* ALTERNATIVE PATHWAY COMPL. TEST

FDA 510(k)

FDA Class 2 ·Immunology

TSH RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur Total IgE (tIgE)

FDA 510(k)

FDA Class 2 ·Immunology

MARDX MITOCHONDRIA EIA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

PASCO MIC AND MIC/ID PANELS (CEFUROXIME)

FDA 510(k)

FDA Class 2 ·Microbiology

PRISMA C-REACTIVE PROTEIN ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

PASCO MIC AND MIC/ID MODIFIED

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SHIGELLA BOYDII TYPE 4 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2

FDA 510(k)

FDA Class 2 ·Immunology

NEW OPTIONAL PROBES FOR SSA-90A

FDA 510(k)

FDA Class 2 ·Radiology

THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC

FDA 510(k)

FDA Class 2 ·Immunology