VENTREX/SEP TSH TEST SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

CMV BRITE TURBO KIT

FDA 510(k)

FDA Class 2 ·Microbiology

HERPES GROUP IGG

FDA 510(k)

FDA Class 2 ·Microbiology

IC MICROASSAY

FDA 510(k)

FDA Class 2 ·Immunology

API UNISCEPT KB/TYPE 2 AND 3

FDA 510(k)

FDA Class 2 ·Microbiology

RHIGENE MESACUP2 TEST- SCL-70

FDA 510(k)

FDA Class 2 ·Immunology

HEMAGEN CMV IGG KIT

FDA 510(k)

FDA Class 2 ·Microbiology

VISTA ANTIGEN SALMONELLA H C

FDA 510(k)

FDA Class 2 ·Microbiology

ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNODIFFUSION REAGENTS/SEROLOGICAL

FDA 510(k)

FDA Class 2 ·Microbiology

SYNELISA TGAB/TMAB

FDA 510(k)

FDA Class 2 ·Immunology

VAST VENTREX RAST ALL

FDA 510(k)

FDA Class 2 ·Immunology

DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Aptiva Celiac Disease IgA Reagent

FDA 510(k)

FDA Class 2 ·Immunology

SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST

FDA 510(k)

FDA Class 2 ·Immunology

SERO/TEX LE TEST

FDA 510(k)

FDA Class 2 ·Immunology

EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology