SENSI-CAL AMCO AEPA-1

FDA 510(k)

FDA Class 2 ·Microbiology

ARIES System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IVD CAPSULE PSP; abioSCOPE

FDA 510(k)

FDA Class 2 ·Microbiology

CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT

FDA 510(k)

FDA Class 2 ·Immunology

RAICHEM(TM) SPIA(TM) APO B REAGENTS

FDA 510(k)

FDA Class 2 ·Immunology

IMX RUBELLA IGM ANTIBODY ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

DIASTAT ANTI-THYROID PEROXIDASE KIT

FDA 510(k)

FDA Class 2 ·Immunology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

DENV DETECT IGM CAPTURE ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Pneumonia/Pneumoniaplus Control

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Imipenem 0.016-256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

THAYER-MARTIN AGAR PLATE

FDA 510(k)

FDA Class 2 ·Microbiology

QUANTA LITE RNP ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ALPHA CRYPTOCOCCAL ANTIGEN EIA

FDA 510(k)

FDA Class 2 ·Microbiology

T2 Biothreat Panel

FDA 510(k)

FDA Class 2 ·Immunology

ETEST SUBMISSION FOR IMIPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207

FDA 510(k)

FDA Class 2 ·Immunology

NEO-PREGNOSTICON DUOCLON TUBE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry