ADVIA Centaur HAV IgM Assay

FDA 510(k)

FDA Class 2 ·Microbiology

BOEHRINGER MANNHEIM IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-HAV IGM

FDA 510(k)

FDA Class 2 ·Microbiology

MONOLISA ANTI-HAV EIA

FDA 510(k)

FDA Class 2 ·Microbiology

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS

FDA 510(k)

FDA Class 2 ·Microbiology

ABBOTT ARCHITECT HAVAB-M

FDA 510(k)

FDA Class 2 ·Microbiology

MONOLISA ANTI-HAV IGM EIA

FDA 510(k)

FDA Class 2 ·Microbiology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·9EPANOSTIKA(TM) ANTI-HAV IGM

RETINA TOMOGRAPH AND FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA ANGIOGRAPH

FDA 510(k)

FDA Class 2 ·Ophthalmic

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E

FDA 510(k)

FDA Class 2 ·General Hospital

Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107

FDA 510(k)

FDA Class 2 ·General Hospital

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)

FDA 510(k)

FDA Class 2 ·General Hospital

Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO

FDA 510(k)

FDA Class 2 ·Immunology