DIGITAL SPOT IMAGING (DSI)

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·THOR PTCA DILATION CATHETERS

ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)

FDA 510(k)

FDA Class 2 ·Microbiology

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

FDA 510(k)

FDA Class 2 ·Microbiology

QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Solana HSV 1+2/VZV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m HSV 1 & 2 / VZV

FDA 510(k)

FDA Class 2 ·Microbiology

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV RNA QUALITATIVE ASSAY AND THE APTIMA HCV RNA QUALITATIVE ASSAY

Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody

FDA classification

FDA Class 2 ·Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody

Fludeoxyglucose F18-Guided Radiation Therapy System

FDA classification

FDA Class 2 ·Fludeoxyglucose F18-Guided Radiation Therapy System

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MICROSCAN RAPID FLUOROGENIC PANELS

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX(R) HAVAB(R)-M

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS TITAN & TITAL XL DILATION CATHETERS