Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

CAREMIBRAIN

FDA 510(k)

FDA Class 2 ·Radiology

PHENYTOIN CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Stomach Tube

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PALMLIGHT

FDA 510(k)

FDA Class 2 ·Dental

PHENYTION EIA TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Well Lead Ureteral Access Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THEOPHYLLINE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FEops HEARTguide

FDA 510(k)

FDA Class 2 ·Cardiovascular

FEops HEARTguideTM, FEops HEARTguideTM ALPACA

FDA 510(k)

FDA Class 2 ·Radiology

Aquarius Stoma Measuring Device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XENX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST

FDA 510(k)

FDA Class 2 ·Microbiology

CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)

FDA 510(k)

FDA Class 2 ·Hematology

IDEIA HERPES SIMPLEX VIRUS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

APTOS Threads – Polypropylene Surgical Sutures

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MRCP+ v1.0

FDA 510(k)

FDA Class 2 ·Radiology

LiverMultiScan

FDA 510(k)

FDA Class 2 ·Radiology