Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Acuitas AMR Gene Panel

FDA 510(k)

FDA Class 2 ·Microbiology

cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Carba-R

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV

FDA 510(k)

FDA Class 2 ·Microbiology

GenePOC Carba

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)

FDA 510(k)

FDA Class 2 ·Microbiology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HEPATITIS C CHECK TESTING SERVICE

Accessories, Solution, Ultrasonic Cleaners For Lenses

FDA Pre-Market Approval

FDA Class 2 ·UNIZYME(TM) ENZYMATIC CLEANER

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

SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC STORMER MX2/OTW BALLOON DILATATION CATHETER