Modus IR

FDA 510(k)

FDA Class 2 ·Radiology

STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TITANIUM CONNECTOR (2 PART)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ABARIS

FDA 510(k)

FDA Class 2 ·Radiology

BrightMatter Plan 1.6.0

FDA 510(k)

FDA Class 2 ·Radiology

PERCUNAV

FDA 510(k)

FDA Class 2 ·Radiology

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

Radioimmunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS

Radioimmunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS

Anti-Mutated Citrullinated Vimentin Igg

FDA classification

FDA Class 2 ·Anti-Mutated Citrullinated Vimentin Igg

Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

FDA classification

FDA Class 2 ·Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

Pulse Generator, External Pacemaker, Dual Chamber

FDA Pre-Market Approval

FDA Class 2 ·REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS