Accessories, Solution, Ultrasonic Cleaners For Lenses

FDA Pre-Market Approval

FDA Class 2 ·UNIZYME(TM) ENZYMATIC CLEANER

MAXCEM 2

FDA 510(k)

FDA Class 2 ·Dental

SCANVIEW SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

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

ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000

FDA 510(k)

FDA Class 2 ·Immunology

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

FDA 510(k)

FDA Class 2 ·Microbiology

Gili Pro BioSensor (also known as “Gili BioSensor System”)

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

SCANVIEW HER2/NEU FISH SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Visby Medical Women's Sexual Health Test

FDA 510(k)

FDA Class 2 ·Microbiology

GENASIS SCANVIEW SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

VYSIS AUTOVYSION SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

SOOTHE-N-SEAL CANKER SORE RELIEF

FDA 510(k)

FDA Class 2 ·Dental

DUET SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Solana HSV 1+2/VZV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

CYTOVISION FOR CEP XY

FDA 510(k)

FDA Class 2 ·Immunology

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