LEFORTE SYSTEM BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)

FDA 510(k)

FDA Class 2 ·Microbiology

STRATIFY JCV(TM) ANTIBODY

FDA 510(k)

FDA Class 2 ·Microbiology

STRATIFY JCV DXSELECT

FDA 510(k)

FDA Class 2 ·Microbiology

SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK

FDA 510(k)

FDA Class 2 ·Microbiology

SIMPLEXA HSV 1&2 DIRECT

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Meningitis/Encephalitis(ME) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa VZV Direct, Simplexa VZV Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

QIAstat-Dx Meningitis/Encephalitis (ME) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch

FDA 510(k)

FDA Class 2 ·Microbiology

CDC DENV-1-4 REAL TIME RT-PCT ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

DENV DETECT IGM CAPTURE ELISA

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

cobas BKV

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

IMDX HSV-1/2 FOR ABBOTT M2000

FDA 510(k)

FDA Class 2 ·Microbiology