Mission Urinalysis Reagent Strips

FDA UDI

ACON LABORATORIES, INC.·00682607000470·Mission Urinalysis Reagent Strips (GLU/KET/PH)

ENERPEEL HANDS

Basic UDI-DI

EU MDD · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP)

ACCURUN 372 HPV DNA Positive Control Series 400

Basic UDI-DI

EU IVDD · Eu Ivd General ·LGC Clinical Diagnostics, Inc.·1 device

ACCURUN 372 HPV DNA Positive Control Series 600

Basic UDI-DI

EU IVDD · Eu Ivd General ·LGC Clinical Diagnostics, Inc.·1 device

ACCURUN 378 HPV DNA Positive Control Series 5000

Basic UDI-DI

EU IVDD · Eu Ivd General ·LGC Clinical Diagnostics, Inc.·1 device

AmoyDx® Human Papillomavirus(HPV) Genotyping Detection Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·1 device

CMV MICROASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

APTT REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

LIQUID CHROMATO. COLUMNS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

COE PAK AUTO MIX, REGULAR OR HARD SET

FDA 510(k)

FDA Class 2 ·Dental

DATASCOPE ARTERIAL CANNULA W/ACCESS PORT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT

FDA 510(k)

FDA Class 2 ·Microbiology

PROTEIN S CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

BIOBRANE(R) II

FDA 510(k)

FDA Unclassified ·Unknown

GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POREX(TM) PROSTHESIS, CHIN, INTERNAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER

FDA 510(k)

FDA Class 2 ·General Hospital

PL 20/20 INFANT VISION TESTER

FDA 510(k)

FDA Class 1 ·Ophthalmic

MODIFICATION TO: VELSCOPE

FDA 510(k)

FDA Class 2 ·Dental