Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN PARVOVIRUS B19 IGG

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® Biotrin Parvovirus B 19 IgG Plus, LIAISON® Biotrin Control Parvovirus B 19 IgG Plus

FilmArray Meningitis/Encephalitis(ME) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa VZV Direct, Simplexa VZV Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

QIAstat-Dx Meningitis/Encephalitis (ME) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch

FDA 510(k)

FDA Class 2 ·Microbiology

LUPUS(LE)-LATEX TEST

FDA 510(k)

FDA Class 1 ·Microbiology

CDC DENV-1-4 REAL TIME RT-PCT ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920

FDA 510(k)

FDA Class 1 ·Microbiology

IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY

FDA 510(k)

FDA Class 1 ·Microbiology

MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES

FDA 510(k)

FDA Class 1 ·Microbiology

PORTRAIT ANALYZER

FDA 510(k)

FDA Class 1 ·Microbiology

SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT

FDA 510(k)

FDA Class 1 ·Microbiology

ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10

FDA 510(k)

FDA Class 1 ·Microbiology

BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE

FDA 510(k)

FDA Class 1 ·Microbiology

CHLAMYDIA (LGV-1)

FDA 510(k)

FDA Class 1 ·Microbiology