43 results · 77ms · Sources: EU EUDAMED, US FDA

Test System, For Drugs Of Abuse

FDA Pre-Market Approval
FDA Class 3 ·AWARE TEST SYSTEM

CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK

FDA 510(k)
FDA Class 2 ·Cardiovascular

CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K

FDA 510(k)
FDA Class 2 ·Cardiovascular

iScreen Vision

FDA UDI
ISCREEN VISION, INC.·00864218000104·The iScreen Vision Screener 3000 is a vision sc...

MICROLINE SCREEN FOR METHAMPHETAMINE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MICROLINE SCREEN FOR PHENCYCLIDINE

FDA 510(k)
FDA Unclassified ·Unknown

INFLAMMA DRY

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MICROLINE SCREEN FOR BENZODIAZEPINE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MIRCOLINE SCREEN FOR COCAINE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MICROLINE SCREEN FOR CANNABINOID

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MICROLINE SCREEN FOR AMPHETAMINE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

RPS ADENO DETECTOR PLUS

FDA 510(k)
FDA Class 1 ·Microbiology

MICROLINE SCREEN FOR OPIATES

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MICROLINE SCREEN FOR BARBITURATES

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DIVERSI-KIT

FDA 510(k)
FDA Class 1 ·Microbiology

Computerized Cognitive Assessment Aid

FDA classification
FDA Class 2 ·Computerized Cognitive Assessment Aid

Processor, Cervical Cytology Slide, Automated

FDA classification
FDA Class 3 ·Processor, Cervical Cytology Slide, Automated

X-Ray Field Indicator Light (Laser)

FDA classification
FDA Class 1 ·X-Ray Field Indicator Light (Laser)

X-Ray Field Indicator Light Field (Non-Laser)

FDA classification
FDA Not Classified ·X-Ray Field Indicator Light Field (Non-Laser)

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

FDA classification
FDA Class 2 ·Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density