189 results · 21ms · Sources: EU EUDAMED, US FDA

QCU ANALYTICAL SOFTWARE PACKAGE

FDA 510(k)
FDA Class 2 ·Radiology

DENV Detect NS1 ELISA

FDA 510(k)
FDA Class 2 ·Microbiology

Dengue Virus Antigen Assay

FDA classification
FDA Class 2 ·Dengue Virus Antigen Assay

ACU-EVAC

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ACU-GUARD

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ACU-RAY

FDA 510(k)
FDA Class 2 ·Radiology

ACU-SUTURE KIT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ADVANCEMED CCU DOCUMENTOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACU-SIZER(TM)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ACU-MASSAGE TABLE

FDA 510(k)
FDA Class 2 ·Physical Medicine

ACU-MICRO-NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

ACU-SLIDE TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ACU-SLIDE-TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)

FDA 510(k)
FDA Class 2 ·Dental

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SAFECARE® THC Urine Strip Test

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

FDA 510(k)
FDA Class 2 ·Clinical Toxicology